Anchor deployment devices and related methods

ABSTRACT

Described here are devices, methods, and kits for the deployment of tissue anchors. In some variations, the devices may comprise a shaft defining a lumen for housing at least one anchor therein and a mechanism for deploying the anchor distally from the lumen. In certain variations, the devices may comprise one or more stop elements. For example, a device may comprise a stop element that limits the advancement of the device through an opening in a wall portion or at the distal end of another device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/052,593, filed on Oct. 11, 2013, now U.S. Pat. No. 9,616,197, whichis a continuation application of U.S. application Ser. No. 12/657,422,filed on Jan. 19, 2010, now abandoned, which claims the benefit of U.S.Provisional Application No. 61/145,964, filed on Jan. 20, 2009, U.S.Provisional Application No. 61/160,230, filed on Mar. 13, 2009, U.S.Provisional Application No. 61/160,670, filed on Mar. 16, 2009, U.S.Provisional Application No. 61/178,910, filed on May 15, 2009, and U.S.Provisional Application No. 61/178,938, filed on May 15, 2009, thedisclosures of all of which are incorporated herein by reference intheir entirety.

TECHNICAL FIELD

The devices, methods, and kits described herein relate generally to thedeployment of one or more implants into a body of a subject. Morespecifically, the devices, methods, and kits described herein relate tothe deployment of one or more anchors into tissue of a subject, such asheart tissue.

BACKGROUND

Many different medical procedures involve the use of implants, such asanchors. Anchors may be used to modify tissue (e.g., by changing theconfiguration of the tissue), to fasten one piece of tissue to another,to fasten tissue to material, and the like. Anchors range in design fromsimple staples or T-bars, to more complex designs having hooks or barbs,to any of a number of other different types of designs. In some cases,anchors that are connected to each other by a tether may be implantedinto tissue, and the tether may then be tensioned to tighten or compressthe tissue (e.g., by bringing two pieces or sections of the tissuetogether). As an example, in some cases, a mitral valve that isexperiencing mitral regurgitation may be repaired by deploying tetheredanchors into tissue in the vicinity of the valve, and tensioning thetether. Tensioning the tether can provide a cinching effect that bringsthe anchors closer together, thereby reducing the circumference of thevalve and alleviating the mitral regurgitation. Devices and methods formitral valve repair are described, for example, in U.S. patentapplication Ser. No. 11/232,190 (published as US 2006/0190030 A1), Ser.No. 11/270,034 (published as US 2006/0122633 A1), and Ser. No.11/583,627 (published as US 2008/0172035 A1), all of which are herebyincorporated by reference in their entirety.

It would be desirable to provide devices, methods, and kits fordeploying implants (e.g., tissue anchors) for use in any of a variety ofprocedures, such as percutaneous procedures and/or surgical procedures.It would also be desirable to provide devices that are relatively easyto use and/or that allow for enhanced control over the deployment ofimplants. Similarly, it would be desirable to provide devices that arecapable of reaching tissues that are not easily accessible.

SUMMARY

Described here are devices, methods, and kits for deploying one or moreimplants, such as one or more anchors, into a target site (e.g., hearttissue) of a subject. These devices, methods, and kits may be used in avariety of procedures, such as percutaneous procedures or surgicalprocedures. In some variations, the devices may comprise one or morestop elements which may be used to control the advancement of thedevices during use, and/or which may be used to control the advancementof one or more components within the devices. As an example, an anchordeployment catheter may comprise one or more external stop elements thatmay be used to help control the advancement of the catheter throughanother device (e.g., another catheter). Alternatively or additionally,the anchor deployment catheter may comprise one or more internal stopelements (e.g., disposed within a lumen of the anchor deploymentcatheter). The internal stop elements may, for example, be used tocontrol advancement of a pushing member within the lumen. For example,an internal stop element may be used to prevent a pushing member frombeing inadvertently pushed out of an anchor deployment catheter (e.g.,when the pushing member is being used to deploy an anchor from thecatheter). While internal and external stop elements are describedherein with reference to anchor deployment catheters, they may be usedwith any other types of catheters or devices for which their use isappropriate.

Some variations of the devices described here may comprise a cathetercomprising a tubular elongated member defining a proximal portion, adistal portion, and a lumen therethrough. The catheter may also comprisea first stop element comprising an elongated flap. A first portion ofthe first stop element may be disposed within the lumen of the tubularelongated member, and/or a second portion of the first stop element mayextend through an opening in a wall portion of the tubular elongatedmember. The catheter may further comprise an anchor disposed within thelumen of the tubular elongated member. In some variations, the cathetermay comprise a coupling member coupled to the anchor. In certainvariations, the catheter may comprise a second stop element (e.g., atubular member) disposed within the lumen of the tubular elongatedmember. The second stop element may be coupled to or integral with thefirst stop element, or may be separate from the first stop element. Incertain variations, the catheter may further comprise a pushing memberincluding a distal portion comprising a first region having a firstcross-sectional diameter and a second region having a secondcross-sectional diameter that is smaller than the first cross-sectionaldiameter. For example, the distal portion of the pushing member may betapered.

Some variations of the devices described here may be anchor deploymentdevices comprising a catheter defining a lumen for housing an anchortherein, a pushing member at least partially disposed within the lumen,and a tubular stop element disposed within the lumen. The pushing memberand the tubular stop element may be configured such that when thepushing member is advanced into the tubular stop element, the tubularstop element limits further distal advancement of the pushing member.The anchor deployment device may further comprise an anchor disposedwithin the lumen of the catheter. The anchor may, for example, becoupled to the tubular stop element. The pushing member may comprise adistal portion comprising a first region having a first cross-sectionaldiameter and a second region having a second cross-sectional diameterthat is smaller than the first cross-sectional diameter. For example,the distal portion of the pushing member may be tapered. The anchordeployment device may comprise a second stop element that is coupled toor integral with the tubular stop element. The second stop element mayextend through an opening in a wall portion of the catheter, and/or maybe in the form of an elongated flap extending from the tubular stopelement.

Certain variations of the devices described here may have shaftscomprising one or more flexible materials. This may render the devicesparticularly useful in percutaneous procedures, for example. In suchvariations, the devices may, for example, have a relatively low profile,consistent with their manipulation through the vasculature. Any suitableflexible material or materials may be used. Non-limiting examples ofmaterials which may be relatively flexible include polymers (e.g.,nylon, polyethylene, polyetheretherketone (PEEK),polytetrafluoroethylene (PTFE), and copolymers such as polyether blockamides and fluorinated ethylene propylene copolymer), polymer blends(e.g., nylon blends), metal alloys (e.g., nickel titanium alloys,stainless steel), and combinations thereof. In certain variations, adevice may comprise one or more polymer blends with a supporting metalbraid or coil.

Some variations of the devices described here may have shafts comprisingone or more relatively rigid materials. This may render the devicesparticularly useful, for example, in open or surgical procedures, whereaccess to the target site is achieved by incision. Non-limiting examplesof materials which may be relatively rigid include metal alloys (e.g.,stainless steel, nickel titanium alloys), polymers (e.g., polypropylene,high density polyethylene (HDPE)), polymer composites (e.g.,carbon-filled nylon, carbon-filled polyetheretherketone), andcombinations thereof.

As discussed above, certain variations of the devices described here areanchor deployment catheters. It should be understood, however, that oneor more features of the anchor deployment catheters described here maybe applied to other types of catheters, or even other types of devices,as appropriate. Some variations of the catheters described here areprimary anchor deployment catheters configured to deploy an anchor thatis fixedly coupled to a coupling member. In certain variations, aprimary anchor deployment catheter may be used to deploy one or moreanchors into a target site at the beginning of an anchor deploymentprocedure. Other variations of the catheters described here comprisesecondary anchor deployment catheters configured to deploy one or moreanchors over a coupling member so that the anchors are slidably coupledto the coupling member. In some variations, a primary anchor deploymentcatheter may be used to deploy an anchor that is fixedly coupled to acoupling member into a target site. As a result, the coupling member maybe secured to the target site, and may thereby serve as a track for theadvancement of one or more secondary anchor deployment catheters to thetarget site. The secondary anchor deployment catheters, in turn, may beused to deploy one or more anchors slidably over the coupling member.The coupling member may also be left at the target site at thecompletion of the anchor deployment procedure, to serve as an implantitself.

The devices described here may also comprise a shaft having at least onepreformed curve. For example, the shaft may have one or more curves nearits distal tip. This may help the devices to access areas that wouldotherwise be difficult to reach. A curve may form an are having anysuitable central angle. For example, a curve may form an arc having acentral angle ranging from about 15 degrees to about 270 degrees (e.g.,from about 45 degrees to about 180 degrees, from about 50 degrees toabout 120 degrees). Alternatively or additionally, a curve may form anarc having an arc diameter of about 5 degrees to about 90 degrees (e.g.,from about 10 degrees to about 70 degrees, from about 20 degrees toabout 50 degrees).

In some variations, a device may comprise a shaft having at least onecurve, and the region of the shaft that is distal to the curve may beplanar relative to at least one other region of the shaft that isproximal to the curve, or even relative to the rest of the shaft. Inother words, the more distal region may define the same plane as themore proximal region or as the rest of the shaft. Alternatively oradditionally, a device may comprise a shaft having a curve, where aregion of the shaft that is distal to the curve defines a plane that isdifferent from a plane defined by at least one other region of the shaftthat is proximal to the curve (e.g., the rest of the shaft). Forexample, a catheter may comprise a shaft having a substantially straightproximal region defining a first plane, a curve distal to thesubstantially straight proximal region, and a region distal to the curvedefining a second plane that is different from the first plane. A shaftof a device may have any appropriate number of curves and planes,depending, for example, on the anatomy of the target site. Moreover, insome cases, a shaft of a device may not have any curves.

The first and second planes defined by two different regions of a shaftof a device may, for example have an angle of about 10 degrees to about90 degrees (e.g., about 20 degrees to about 80 degrees, about 30 degreesto about 75 degrees, about 40 degrees to about 70 degrees, or about 50degrees to about 60 degrees, such as about 50 degrees or about 60degrees) therebetween. As an example, in some variations a primaryanchor deployment catheter may comprise a shaft having a first regiondefining a first plane and a second region defining a second plane,where the angle between the first and second planes is about 60 degrees.As another example, in certain variations a secondary anchor deploymentcatheter may comprise a shaft having a first region defining a firstplane and a second region defining a second plane, where the anglebetween the first and second planes is about 50 degrees. The anglebetween any two planes defined by different regions of a device shaftmay be selected, for example, based on the anatomical characteristics ofthe target site, and/or based on other devices to be used in conjunctionwith the device.

In some variations, a device may comprise a shaft having multipledifferent regions with curves between the different regions. At leasttwo of the regions may define the same plane, and/or at least two of theregions may define different planes.

As used herein, values and ranges provided for an angle between twoplanes may refer to the smaller angle between the two planes. Forexample, if two planes intersect to define two 30-degree angles and two150-degree angles, then the smaller angle would be one of the 30-degreeangles. Alternatively or additionally, in some variations in which ashaft comprises a first region defining a first plane, a second regiondefining a second plane, and a third region defining a third plane,values and ranges provided herein for an angle between two of the planesmay refer to an angle located within a space defined by the threeplanes. In certain variations, values and ranges provided herein for anangle between two of the planes may refer to an angle located outside ofa space defined by the three planes.

In some variations, the devices described here may comprise a shafthaving at least one inflection point, either in addition to, or as analternative to, having at least one preformed curve. The inflectionpoint may, for example, be located in a distal portion of the shaft. Thecurves and inflection points in a catheter may be designed to helpposition the catheter at a desired target site, and/or to help thecatheter serve a particular function (e.g., deployment of anchors intoheart valve annular tissue).

In certain variations, the devices may comprise at least two shafts.This may, for example, allow the devices to deploy multiple anchorssimultaneously. Similarly, a single shaft of a device comprising atleast one shaft may be configured to receive at least two anchorstherein, for deploying multiple anchors serially or sequentially. Thedevices may have any suitable mechanism for deploying the anchors fromthe distal end of the shaft. For example, the mechanism may be ahydraulic mechanism, or a pressurized air mechanism. In some variations,the mechanism may comprise a pushing member slidably disposed within atleast a portion of a lumen in the shaft. In some such variations, thedevice may comprise an actuator for actuating the pushing member.

Certain variations of the methods described here may comprise advancinga first catheter through a lumen of a second catheter, and advancing aportion of the first catheter through an opening in a wall portion or ata distal end of the second catheter. The portion of the first cathetermay be advanced through the opening until the wall portion of the secondcatheter is positioned (e.g., wedged) between a wall portion and a stopelement of the first catheter. The positioning of the wall portion ofthe second catheter between the wall portion and stop element of thefirst catheter may prevent further advancement of the first catheterthrough the opening in the wall portion or at the distal end of thesecond catheter.

The stop element of the first catheter may remain within the lumen ofthe second catheter while the portion of the first catheter is advancedthrough the opening in the wall portion or at the distal end of thesecond catheter. Advancing the portion of the first catheter through theopening may comprise pushing the portion of the first catheter throughthe opening with a pushing member. Some variations of methods maycomprise deploying an anchor from the first catheter after the firstcatheter has been advanced through the opening in the wall portion or atthe distal end of the second catheter. In certain variations, the anchormay be retrieved after it has been deployed. In some variations, theportion of the first catheter may be withdrawn back into the lumen ofthe second catheter after the anchor has been deployed from the firstcatheter. The stop element may comprise an elongated flap. In certainvariations, the elongated flap may extend through an opening in the wallportion of the first catheter. In some variations, the elongated flapmay curve away from the wall portion of the first catheter as the wallportion of the second catheter becomes positioned between the wallportion and stop element of the first catheter.

In certain variations, a method for deploying an anchor into tissue of asubject may comprise advancing a distal portion of a pushing member intoa tubular stop element disposed within a lumen of a first catheter,Where the tubular stop element is coupled to an anchor. The method mayalso comprise advancing the distal portion of the pushing member againstthe anchor to deploy the anchor from the lumen of the first catheter andinto tissue of a subject. The distal portion of the pushing member andthe tubular stop element may be configured to limit further distaladvancement of the pushing member once the distal portion of the pushingmember has been advanced into the tubular stop element. In somevariations, the method may comprise using the pushing member to decouplethe anchor from the tubular stop element. In certain variations, thedistal portion of the pushing member may comprise a first region havinga first cross-sectional diameter and a second region having a secondcross-sectional diameter that is smaller than the first cross-sectionaldiameter. For example, the distal portion of the pushing member may betapered. In some variations, the method may comprise advancing the firstcatheter through an opening in a wall portion or at a distal end of asecond catheter. The tubular stop element may be coupled to or integralwith a second stop element that extends through an opening in a wallportion of the first catheter. The advancement of the first catheterthrough the opening in the wall portion or at a distal end of the secondcatheter may stop when the wall portion of the second catheter becomespositioned between (e.g., wedged between) the second stop element and awall portion of the first catheter. In certain variations, the secondstop element may comprise an elongated flap extending from the tubularstop element.

Some variations of the methods described here may comprise passing acoupling member through an eyelet of an anchor, loading the couplingmember and anchor into a lumen of a shaft, and deploying the anchor.Some variations of the methods described here may comprise loading ananchor within a lumen of a shaft and deploying the anchor distally fromthe lumen. In certain variations in which the anchor comprises aneyelet, the inner diameter of the lumen of the shaft may be the samesize as, or smaller than, the diameter of the eyelet of the anchor whenthe anchor is in an expanded configuration. Alternatively, the innerdiameter of a lumen of the shaft may be larger than the diameter of theeyelet of the anchor when the anchor is in an expanded configuration.Certain methods described here may also comprise retrieving the anchor(e.g., in the event of misplacement).

Also described here are kits for the deployment of tissue anchors. Ingeneral, the kits may comprise one or more anchor deployment devices,such as one or more anchor deployment catheters. For example, a kit maycomprise a primary anchor deployment catheter and one or more secondaryanchor deployment catheters. The kits may further comprise one or moreguide catheters, guide tunnels, and/or termination devices, such aslocking catheters and/or cutting catheters. In some variations, the kitsmay comprise instructions on using the kit. The components of the kitmay be packaged together, or two or more of the components may bepackaged separately from each other.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate the tightening or compression of tissue of asubject using a tether.

FIG. 2A is an illustrative depiction of a cross-sectional view of aheart, and

FIG. 2B is another illustrative depiction of a cross-sectional view ofthe heart of FIG. 2A, with a variation of a catheter advanced throughthe aorta and into the left ventricle.

FIG. 3 is a flowchart representation of a variation of a method fordeploying anchors into a subvalvular space of a heart.

FIGS. 4A-4I schematically depict a variation of a method for deployingmultiple tissue anchors into a subvalvular space of a heart.

FIG. 5A is a perspective view of a variation of an anchor deploymentdevice;

FIG. 5B is an enlarged view of region 5B of FIG. 5A; FIG. 5C is anenlarged view of region 5C of FIG. 5A; FIG. 5D is an enlarged view ofregion 5D of FIG. 5C; FIGS. 5E-5G are different perspective views of adistal portion of the anchor deployment device of FIG. 5A; FIGS. 5H and5I are side views of the anchor deployment device of FIG. 5A; FIG. 5J isa cross-sectional view of the anchor deployment device as shown in FIG.5I, taken along line 5J-5J; FIG. 5K is an enlarged view of region 5K ofFIG. 5I; and FIG. 5L is an enlarged view of region 5L of FIG. 5I.

FIGS. 5M-5R depict different variations of pushing members for anchordeployment devices.

FIG. 5S is an illustrative depiction of a variation of a method fordeploying anchors using the anchor deployment device of FIG. 5A, andFIG. 5T is an illustrative depiction of another variation of a methodfor deploying anchors using another variation of an anchor deploymentdevice.

FIGS. 5U-5X depict additional variations of anchor deployment devices.

FIG. 6A is a perspective view of another variation of an anchordeployment device; FIG. 6B is an enlarged view of region 6B of FIG. 6A;FIGS. 6C and 6D depict the enlarged view of FIG. 6B after it has beenrotated; FIG. 6E is an enlarged view of region GE of FIG. 6A; FIG. 6F isan enlarged view of region 6F of FIG. 6E; FIGS. 6G-6I are differentperspective views of a distal portion of the anchor deployment device ofFIG. 6A; FIGS. 6J and 6K are side views of the anchor deployment deviceof FIG. 6A; FIG. 6L is a cross-sectional view of the anchor deploymentdevice as shown in FIG. 6K, taken along line 6L-6L; FIG. 6M is anenlarged view of region 6M of FIG. 6K; and FIG. 6N is an enlarged viewof region 6N of FIG. 6K.

FIG. 6O depicts a tether routed through a portion of the anchordeployment device of FIG. 6A.

FIG. 7A is an illustrative depiction of a front view of a variation ofan anchor deployment device; FIG. 7B is schematic illustration of thegeometry of the anchor deployment device of FIG. 7A, and FIG. 7C is anillustrative depiction of a variation of a method of using the anchordeployment device of FIG. 7A in heart tissue of a subject.

FIG. 8A is an illustrative depiction of a front view of anothervariation of an anchor deployment device; FIG. 8B is schematicillustration of the geometry of the anchor deployment device of FIG. 8A,and FIG. 8C is an illustrative depiction of a variation of a method ofusing the anchor deployment device of FIG. 8A in heart tissue of asubject.

FIG. 9A is an illustrative side view of a variation of an anchordeployment device that may be used to deploy multiple anchors; FIG. 9Bis an illustrative top view of a portion of the anchor deployment deviceof FIG. 9A; and FIG. 9C is an illustrative depiction of a component ofthe anchor deployment device of FIG. 9A.

FIGS. 10A and 10B are illustrative variations of devices for loadingtethers into devices or device components, such as catheters.

FIGS. 11A and 11B depict exemplary illustrations of variations of anchorretrieval mechanisms and methods.

FIGS. 12A-12D are cross-sectional views of a portion of a heart,schematically illustrating the positioning and deployment of a variationof a tissue anchor into a region of a mitral valve annulus.

FIG. 13 shows a transseptal approach to the left ventricle of a heart

FIG. 14 shows a transapical approach to the left ventricle of a heart.

DETAILED DESCRIPTION

Described here are devices, methods, and kits for deploying one or moreimplants, such as one or more anchors, into tissue (e.g., heart tissue)of a subject. In some variations, multiple implants may be coupled toeach other with a coupling member (e.g., a tether), which may betensioned to tighten or compress tissue, such as soft tissue. Softtissue includes, for example, muscle tissue and fat tissue, while hardtissue includes, for example, bone tissue. The devices, methods, andkits described here may be used in percutaneous procedures (where accessto the anchor deployment site is achieved intravascularly), or in opensurgical procedures (where access to the anchor deployment site isachieved via incision). While not so limited, the devices, methods, andkits described here may be used, for example, in the fields of generalsurgery, cardiology, urology, neurosurgery, gastroenterology, and thelike. Exemplary procedures include repair of heart valves (e.g., mitral,tricuspid, aortic), repair or reduction of sphincters, closure ofwounds, and reduction of the circumference of the gastroesophagealjunction. Some variations of the devices, methods, and/or kits describedhere may be used in endoscopic procedures (e.g., laparoscopy and/orarthroscopy). Certain variations of the devices, methods, and/or kitsdescribed here may be used in Natural Orifice Transluminal EndoscopicSurgery (“NOTES”) procedures. In general, the devices, methods, and kitsmay be used with any of a variety of different anchors. For example, thedevices may be used with anchors of any desirable size, the size of theanchor being largely dependent upon the procedure to be carried out.Specific examples of the devices, methods, and kits will now bedescribed in further detail below.

Turning now to the figures, FIG. 1A shows two anchors (100) and (104)anchored into tissue (106) of a subject. A coupling member (as shown, atether (110)) is fixedly attached to anchor (100), and is threadedthrough a loop region (114) of anchor (104). As shown in FIG. 1B, whentether (110) is pulled upon in the direction of arrow (A1), a cinchingeffect results, such that anchors (100) and (104) are brought closertogether, and the tissue length between anchors (100) and (104) isreduced. In this way, tissue (106) is compressed between anchors (100)and (104). It should be understood that while two anchors are shown inFIGS. 1A and 1B, in some cases multiple anchors may be used. Aftertether (110) has been tensioned by a desired amount, tether (110) may belocked to maintain the tension, and in some cases, excess portions oftether (110) may be cut and removed.

As discussed above, in some variations, one or more of the devices,methods, and/or kits described here may be used to deploy one or moreanchors to tissue in the vicinity of a heart valve during a heart valverepair procedure (e.g., a mitral valve repair procedure). Heart valverepair procedures will now be discussed in further detail below.

FIG. 2A shows a cross-sectional view of a heart (H) including an aorta(AO), a superior vena cava (SVC), a right atrium (RA), a right ventricle(RV), a left atrium (LA), and a left ventricle (LV). As shown in FIG.2A, a mitral valve (MV) comprising mitral valve leaflets (MVL) separatesleft atrium (LA) from left ventricle (LV), while a tricuspid valve (TV)comprising tricuspid valve leaflets (TVL) separates right atrium (RA)from right ventricle (RV). There are two mitral valve leaflets (MVL),the anteromedial leaflet and the posterolateral leaflet. In some cases,mitral valve leaflets (MVL) and/or tricuspid valve leaflets (TVL) may bereferred to more generally herein as leaflets (L). Additionally, heart(H) includes papillary muscles in its right ventricle (RVPM), as well aspapillary muscles in its left ventricle (LVPM). Both the mitral valveand the tricuspid valve comprise a valve annulus (not shown), discussedin further detail below.

FIG. 2A also shows a primary chorda tendinea (PCT), secondary chordatendinea (SCT), and tertiary chorda tendinea (TCT) in left ventricle(LV)—of course, these are only illustrative chordae tendineae, and aheart generally has more than one of each of these different types ofchordae tendineae. The chordae tendineae (also referred to herein as“chords”) are tendons in the left and right ventricles of the heart,some of which connect the heart's papillary muscles to its mitral andtricuspid valves. These chords help to ensure unidirectional flowthrough the valve leaflets, preventing the valves from moving into theatria when the ventricles contract. Primary or first-order chords attachpapillary muscles to the free edges of the valve leaflets, secondary orsecond-order chords attach papillary muscles to the ventricular surfacesof the valve leaflets, and tertiary or third-order chords connect theventricular walls to the undersurfaces of the posterolateral leaflets.

As shown in FIG. 2A, right ventricle (RV) includes a subvalvular space(205), and left ventricle (LV) includes a subvalvular space (206). Thesubvalvular space, as used herein, generally includes the portion of theventricular chamber that is bound peripherally by the ventricular wall(VW), superiorly by the atrio-ventricular valve leaflets, and centrallyby the primary chordae tendineae (PCT), and is located along thecircumference of the valve annulus. Additionally, the subannular grooveregion (204), as used herein, includes the space bordered by the innersurface of the ventricular wall (VW), the inferior surface of valveleaflets (MVL) or (TVL), and the tertiary chordae tendineae (TCT)connected directly to the ventricular wall (VW) and a leaflet (L). WhileFIG. 2A shows subannular groove region (204) in left ventricle (LV), itshould be understood that right ventricle (RV) has a correspondingsubannular groove region, as well. Devices and methods described herewith respect to the subannular groove region in the left ventricle may,of course, be used in the subannular groove region of the rightventricle, as appropriate.

FIG. 2B shows a cross-sectional depiction of heart (H) with onevariation of a catheter (200) advanced in a retrograde direction throughaorta (AO) and into left ventricle (LV) (e.g., after being inserted intothe femoral artery). Catheter (200) may, for example, be a guidecatheter; which will be discussed in further detail below, Retrograde,as used herein, generally refers to a direction opposite the expectedflow of blood. This access route may be used to reach subvalvular space(206). The distal portion of catheter (200) may then be advanced, forexample, under the posterolateral mitral valve leaflet and intosubannular groove region (204). In some variations, catheter (200) maybe a generally flexible elongate catheter which may have one or morecurves or bends toward its distal end. The curves or bends mayfacilitate placement of the distal end (202) of catheter (200) at thedesired location. Distal end (202) of catheter (200) may be configuredto be positioned at an opening into subvalvular space (206) or withinsubvalvular space (206), such that subsequent devices (e.g., anchordeployment catheters) may be passed through catheter (200) and intosubvalvular space (206). Although the retrograde aortic access routepreferably starts from a percutaneous or peripheral access site, in somevariations, aortic access may be achieved by an incision in theascending aorta, descending aorta, aortic arch or iliac arteries,following surgical, thorascopic or laparoscopic access to a body cavity.

In certain variations, other spaces bound by or relating to one or morecardiac structures may be used as a target region of the heart. Thesestructures include but are not limited to the base of the ventricle, themitral valve, the tricuspid valve, the primary chordae tendineae, thesecondary chordae tendineae, the tertiary chordae tendineae, theanterior mitral valve leaflet chordae tendineae, the posterior mitralvalve leaflet chordae tendineae, the interleaflet chordae tendineae, thepapillary muscle, the anterior-lateral papillary muscle, theposterior-medial papillary muscle, the ventricular apical region, andthe ventricular apex. As an example, in some variations, a supra-apicalspace from about the base of the mitral valve leaflets to just above theventricular apex or apical region may be the target region. As anotherexample, in certain variations, the target region may be theperi-papillary muscle region, which includes the space about onecentimeter above and about one centimeter below the level of thepapillary muscle region, as well as the spaces between the papillarymuscles. In some variations, the target region may be the endocardialsurface abutting or accessible from the given space or cardiacstructures. In still other variations, the target region may be a regionlocated between the base and apex of a ventricle and betweenlongitudinal borders drawn through the papillary muscles (e.g., either aposterior-lateral or an anterior-medial ventricular endocardialsurface). In other variations, the target region may exclude the spacealong the longitudinal axis from the base of a ventricle to the apex ofthe ventricle (e.g., the target region may be tubular or toroidal inconfiguration, with an internal border relating to a chorda tendinea).

FIG. 3 provides a flowchart depiction of one variation of a method (300)for deploying at least two anchors of an implant into the region of aheart valve annulus. As shown there, this illustrative method comprisesadvancing a guide catheter to a subannular groove region of a heart(380), advancing a guidewire through a lumen of the guide catheter(384), advancing a guide tunnel over the guidewire (386), and proximallywithdrawing the guidewire from the guide tunnel (388). The guidecatheter may be advanced into and positioned within the body underfluoroscopic guidance, for example. In some cases, the accessibility ofthe subannular groove region may be verified prior to advancement of theguide catheter to the subannular groove region using a diagnosticcatheter). Devices, methods, and kits for verifying the accessibility ofa target site are described, for example, in U.S. ProvisionalApplication Ser. Nos. 61/145,964, filed on Jan. 20, 2009; 61/160,670,filed on Mar. 16, 2009; and 61/178,938, filed on May 15, 2009, all ofwhich are hereby incorporated by reference in their entirety.

The guide tunnel may, for example, comprise an outer catheter with apassageway in which an inner catheter slidably resides. However, otherappropriate variations of guide tunnels may also be used. After theguidewire has been proximally withdrawn from the guide tunnel (388), aprimary anchor deployment catheter may be advanced through the lumen ofthe guide tunnel (390), and a first anchor may be deployed through afirst opening of the guide tunnel and into a first region of the heartvalve annular tissue (392). The first anchor is typically coupled orsecured to a coupling member, such as a tether. In this way, after thefirst anchor is secured to heart tissue, the coupling member will remaincoupled to the first anchor. While the coupling member may be used as atrack or monorail for the advancement of additional anchor deploymentcatheters thereover, the coupling member is also a component of theimplant that interconnects the multiple anchors. A portion of thecoupling member facilitates the tightening of the implant and remains inthe body with the anchors after the anchor deployment system is removedfrom the body.

After the first anchor has been deployed in the region of the heartvalve annular tissue, the primary anchor deployment catheter may beproximally withdrawn from the guide tunnel. While maintaining theexisting position of the outer catheter of the guide tunnel about thesubannular groove region, the inner catheter of the guide tunnel may berepositioned at a second opening of the outer catheter (394). Asecondary anchor deployment catheter may then be advanced over thecoupling member through the lumen of the guide tunnel (396).

During advancement of the secondary anchor deployment catheter over thecoupling member, the coupling member may enter the secondary anchordeployment catheter through an opening at its distal end, and exit thesecondary anchor deployment catheter through an opening in its side wallthat is proximal to its distal end. Alternatively, the coupling membermay enter the secondary anchor deployment catheter through an opening atits distal end, and exit the secondary anchor deployment catheterthrough an opening at its proximal end, or at any other locationproximal to the distal end. After the secondary anchor deploymentcatheter has been advanced over the coupling member through the lumen ofthe guide tunnel, a second anchor may be deployed from the secondaryanchor deployment catheter into a second region of the heart valveannular tissue using a second opening of the guide tunnel (398). In somevariations, the secondary anchor deployment catheter may be used todeploy one or more additional anchors, and/or one or more other anchordeployment catheters may be used to deploy one or more additionalanchors.

While method (300) has been described above, other variations of methodsmay be employed, depending on the needs of the patient and operatorpreference. As an example, in some variations, after a first anchor hasbeen deployed using the primary anchor deployment catheter, subsequentdeployment of anchors may be achieved by removing and reloading theprimary anchor deployment catheter (as an alternative to, or in additionto, using one or more secondary anchor deployment catheters). In othervariations, the primary anchor deployment catheter may be loaded with aplurality of anchors and may not need to be withdrawn from the guidetunnel to deploy subsequent anchors. As another example, in certainvariations, multiple (i.e., at least two) anchors may be deployedthrough a single window of a guide tunnel using primary and/or secondaryanchor deployment catheters. For example, two or more anchors may bedeployed through the first opening of a guide tunnel. In somevariations, multiple anchors may be deployed through a distal-mostopening in a guide tunnel, and multiple anchors may also be deployedthrough a proximal-most opening in the guide tunnel. This may, forexample, result in enhanced stability for the overall implant. Othersuitable variations of anchor deployment methods may also be used.

FIGS. 4A-4I provide a more detailed depiction of the method shown inflowchart form in FIG. 3. As shown there, mitral valve (MV) is depictedschematically from an inferior perspective looking in a superiordirection, but in other variations the tricuspid valve, pulmonary valveor aortic valve may be accessed. First, and as shown in FIG. 4A, a guidecatheter (440) may be advanced to a subannular groove region (404) usingany of the access routes (or any other suitable access routes) describedherein. Guide catheter (440) may have a size of, for example, 6 Fr to 16Fr (i.e., an outer diameter of 2 millimeters to 5.33 millimeters), suchas 14 Fr (i.e., an outer diameter of 4.67 millimeters), although othersuitable sizes may also be used. In some variations, guide catheter(440) may have an atraumatic tip (e.g., to limit the likelihood ofdamage to tissue during advancement of the guide catheter). Guidecatheters are described, for example, in U.S. Provisional ApplicationSer. Nos. 61/145,964, filed on Jan. 20, 2009; 61/160,670, filed on Mar.16, 2009, and 61/178,938, filed on May 15, 2009, each of which waspreviously incorporated by reference in its entirety.

As shown in FIG. 4B, after guide catheter (440) has been positioned atthe desired location in subannular groove region (404), a guidewire(444) may be advanced through a lumen of guide catheter (440). Guidewire(444) may be advanced beyond the distal end (446) of guide catheter(440), so that guidewire (444) extends farther along subannular grooveregion (404) than guide catheter (440), as shown in FIG. 4B.

After guidewire (444) has been positioned in subannular groove region(404), a guide tunnel (448) may be advanced through guide catheter(440), over guidewire (444), as shown in FIG. 4C. Referring to FIG. 4C,a distal portion (442) of guidewire (444) extends from the distal end ofguide tunnel (448). Guide tunnel (448) may be any suitable catheter, andin some instances, it may be desirable for the guide tunnel to bepre-shaped or pre-formed at its distal end, such as the guide tunnelillustrated in FIG. 4C. In certain variations, guide tunnel (448) mayhave a pre-shaped distal portion that is curved. In this way, the guidetunnel may more easily conform to the geometry of the atrio-ventricularvalve. It should also be understood that any of the catheters orguidewires described here may be pre-shaped or pre-formed to include anynumber of suitable curves, angles or configurations. Of course, theguidewires and/or catheters described here may also be steerable. Guidetunnels are described, for example, in U.S. patent application Ser. No.12/366,553 (published as US 2009/0222083 A1), which is herebyincorporated by reference in its entirety. Curved catheters aredescribed, for example, in U.S. Provisional Application Ser. Nos.61/145,964, filed on Jan. 20, 2009; 61/160,670, filed on Mar. 16, 2009;and 61/178,938, filed on May 15, 2009, each of which was previouslyincorporated by reference in its entirety.

Referring now to FIG. 4D, after guide tunnel (448) has been positionedin subannular groove region (404), guidewire (444) may be withdrawnproximally. A primary anchor deployment catheter (not shown) may then beadvanced through the lumen of guide tunnel (448) and toward an opening(454) at or adjacent to the distal tip (456) of guide tunnel (448).

In the variation depicted in FIG. 4E, the primary anchor deploymentcatheter remains within guide tunnel (448), and an anchor (458) isdeployed through opening (454) to attach to the body tissue. In othervariations, however, the primary anchor deployment catheter may beextended through opening (454) of guide tunnel (448). While anchordeployment catheters are described herein, additional exemplaryvariations of anchor deployment catheters are described, for example, inU.S. patent application Ser. No. 11/583,627 (published as US2008/0172035 A1), which is hereby incorporated by reference in itsentirety, and in U.S. patent application Ser. No. 12/366,553 (publishedas US 2009/0222083 A1), which was previously incorporated by referencein its entirety.

In some variations, opening (454) may be the distal-most anchordeployment opening of guide tunnel (448). In certain variations, one ormore openings may have a separate lumen in guide tunnel (448), so thatany anchors deployed from such openings would not interfere with orrestrict the deployment of subsequent tissue anchors distal to thoseopenings. Furthermore, although FIG. 4F depicts opening (454) as a sideopening of guide tunnel (448), in some variations, opening (454) may belocated at distal tip (456) and may be the same opening shown with adistally protruding guidewire (444) in FIG. 4C.

Anchor (458), shown in FIG. 4E, is preferably a self-expanding design asit exits the anchor deployment catheter and guide tunnel (448) toself-secure into the annular tissue accessible from subannular grooveregion (404). It should be understood that one or more anchors of animplant may be deployed into the annulus directly, while other anchorsmay be secured to other tissue in the vicinity of subannular grooveregion (404). For example, one or more anchors may be secured to thetissue below the annulus. Anchor deployment may be monitored, forexample, under fluoroscopy. After anchor (458) has been deployed, theprimary anchor deployment catheter may be proximally withdrawn.Alternatively, in some variations, the primary anchor deploymentcatheter may be used to deploy one or more additional anchors throughthe same opening in the guide tunnel, prior to being proximallywithdrawn. A tether (460), attached to anchor (458) and seen best inFIGS. 4G and 4H, may be used to facilitate the insertion of additionalanchor deployment catheters toward the implantation site.

In this particular variation, as demonstrated in FIG. 4F, guide tunnel(448) is maintained in the same position while additional anchors (464)and (458′) are deployed from additional openings (464′) and (454′) alongguide tunnel (448). In some variations, one or more secondary anchordeployment catheters may be serially inserted into guide tunnel (448),using tether (460) to serially guide anchors (464) and (458′) throughopenings (464′) and (454′). While not shown here, in certain variations,multiple anchors may be deployed through a single opening in a guidetunnel (e.g., by multiple different anchor deployment catheters, or by asingle anchor deployment catheter). For example, an anchor deploymentcatheter may be used to deploy an anchor through an opening in a guidetunnel. Then, the guide tunnel maybe moved to adjust the position of theopening relative to the anatomy. After the guide tunnel has been moved,another anchor may be deployed through the same opening in the guidetunnel, either by the same anchor deployment catheter, or by a differentanchor deployment catheter. Thus, an opening in a guide tunnel may beused in the deployment of one anchor or multiple anchors, or in somecases, may not be used in the deployment of any anchors (e.g., whenother openings in the guide tunnel are used instead).

In certain variations, the anchor deployment catheters may be loadedwith one or more anchors at the point-of-use, while in other variationsthe anchor deployment catheters may be pre-loaded at thepoint-of-manufacture. In some variations, the anchor deploymentcatheters may be reloaded at the point-of-use, while in othervariations, the anchor deployment catheters may be single-use devicesthat are discarded after anchor deployment. In certain variations, theanchor deployment catheters may be configured to hold two or moreanchors (e.g., anchors (458), (458′), and (464)), and may be able todeploy multiple anchors without requiring withdrawal of the anchordeployment catheter between anchor deployments. In some variations,multi-anchor deployment catheters may be configured to deploy multipleanchors simultaneously through multiple openings of guide tunnel (448),and/or to deploy multiple anchors simultaneously through at least oneindividual opening of guide tunnel (448).

Anchors (e.g., anchors (458), (458′) and (464)) may be deployed from theanchor deployment catheter and guide tunnel (448) in any suitablefashion, including but not limited to using a push-pull wire, a plungeror pushing member, or any other suitable actuation technique. Similarly,anchors may be coupled to tether (460) by any suitable coupling method.For example, one or more knots, welded regions, and/or adhesives may beused. In some variations, crimping and/or tying techniques may beemployed. Alternate variations for anchor deployment and anchorcouplings are described, for example, in U.S. patent application Ser.No. 11/583,627 (published as US 2008/0172035 A1), which is herebyincorporated by reference in its entirety.

In the variations depicted in FIGS. 4A-4I, before a secondary anchordeployment catheter is advanced through guide tunnel (448), tether (460)may be threaded into the secondary anchor deployment catheter andslidably engaged with a second anchor (464). In some variations, secondanchor (464) may be preloaded into the secondary anchor deploymentcatheter before threading tether (460), while in other variations, thesecond anchor may be pre-threaded before being loaded into the secondaryanchor deployment catheter. Any of a number of different methods may beused to thread a coupling member, such as tether (460), into an anchordeployment catheter, and to engage the coupling member with an anchor.Exemplary methods are described, for example, in U.S. patent applicationSer. No. 11/202,474 (published as US 2005/0273138 A1), which is herebyincorporated by reference in its entirety. Additionally, threadingdevices are described, for example, in U.S. patent application Ser. No.11/232,190 (published as US 2006/0190030 A1), which was previouslyincorporated by reference in its entirety.

With reference to FIG. 4H, after all of anchors (458), (458′) and (464)have been deployed into body tissue, guide tunnel (448) may be withdrawnfrom guide catheter (440). A termination catheter (474) may then beinserted through guide catheter (440), over tether (460). Terminationcatheter (474) may be used to facilitate tensioning of tether (460),thereby cinching anchors (458), (458′) and (464) together to remodel theannular tissue. This cinching effect may be viewed, for example, usingultrasound. Termination catheter (474) may also be used to secure thecinched anchors (458), (458′) and (464) with a termination member (476)that resists tether loosening or slippage, as illustrated in FIG. 4I. Inother variations, termination catheter (474) may secure tether (460) toan anchor or to body tissue without the use of a termination member.Devices and methods for performing termination of cinchable implants aredescribed, for example, in U.S. patent application Ser. No. 11/232,190(published as US 2006/0190030 A1) and Ser. No. 11/270,034 (published asUS 2006/0122633 A1), both of which were previously incorporated byreference in their entirety, and in U.S. patent application Ser. No.12/253,885, filed on Oct. 17, 2008, and Ser. No. 12/480,568, filed onJun. 8, 2009, both of which are hereby incorporated by reference intheir entirety.

While one variation of a heart valve repair procedure has beendescribed, other variations of heart valve repair procedures may also beused. Mitral valve repair procedures are described, for example, in U.S.patent application Ser. No. 11/232,190 (published as US 2006/0190030A1), Ser. No. 11/270,034 (published as US 2006/0122633 A1), and Ser. No.11/583,627 (published as US 2008/0172035 A1), all of which werepreviously incorporated by reference in their entirety, and in U.S.patent application Ser. No. 11/656,141 (published as US 2008/0177380A1), which is hereby incorporated by reference in its entirety.

As described above, one or more anchor deployment catheters may be usedin an anchor deployment procedure. Certain variations of anchordeployment catheters may be particularly suitable for percutaneousprocedures. For example, the catheters may be made of one or moreflexible materials and/or may have a relatively low profile. Othervariations of anchor deployment catheters may be particularly suitablefor surgical procedures. For example, the catheters may be made of oneor more relatively rigid materials. Other types of anchor deploymentdevices may also be used, as appropriate. The devices generally areconfigured to deploy tissue anchors, and as such, may be useful in anyvariety of procedures, including those procedures mentioned above. Thedevices may be especially useful in deploying anchors in areas of thebody that are somewhat difficult to access. Moreover, in somevariations, the devices may include one or more features that allow forenhanced control over the devices and over the anchor deployment processduring use.

Some of the described devices comprise a shaft having a lumen forhousing at least one anchor therein, and a mechanism for deploying theanchor distally from the lumen. The corresponding anchor may compriseone or more eyelets and may have an expanded configuration and acollapsed configuration. When the anchor is in its collapsedconfiguration, it may have a relatively small profile, which may enablethe anchor to be housed within the lumen of the device shaft. When theanchor is deployed from the lumen, however, the anchor may assume itsexpanded configuration as it expands and secures into tissue. In somevariations, the inner diameter of the lumen may be the same size as, orsmaller than, the diameter of the eyelet of the anchor to be disposedtherein when the anchor is in its expanded configuration. In some suchvariations, the legs of the anchor may be able assume a more linearshape when the anchor initially exits the lumen. The legs of the anchormay then assume a more curved shape as full expansion occurs. This may,for example, allow the anchor to securely implant into body tissue upondeployment. In certain variations, a device may comprise a shaft havinga lumen for housing at least one anchor comprising at least one eyelet,where the inner diameter of the lumen is larger than the diameter of theeyelet.

As described briefly above, in certain variations of methods, a primaryanchor deployment catheter may be used to deploy one or more anchorsthat are fixedly coupled to a coupling member. Upon deployment of theanchor or anchors into tissue, the coupling member tray effectivelybecome anchored to the tissue, as well. The coupling member may then beused as a track for other anchor deployment catheters to deployadditional anchors over the coupling member. Examples of such anchordeployment methods are described in U.S. patent application Ser. No.11/583,627 (published as US 2008/0172035 A1), which was previouslyincorporated by reference in its entirety.

FIGS. 5A-5L provide an illustrative depiction of a variation of aprimary anchor deployment catheter (500). First, and referringspecifically to FIGS. 5A-5C, primary anchor deployment catheter (500)comprises a proximal operating portion (502) and an elongated shaft(504) including a distal anchor deployment portion (506). Shaft (504)defines a lumen (508) (FIG. 5C), and includes a mechanism for deployingone or more anchors distally from the lumen, which will be described inmore detail below.

While lumen (508) is generally circular in cross-section (FIG. 5J), alumen of an anchor deployment catheter may have any suitablecross-section. For example, a lumen may have an ellipticalcross-section, a rectangular cross-section, or any other geometricallydesirable cross-section. When referring to the “inner diameter” of thelumen in those instances in which a non-circular cross-section is used(e.g., when an elliptical cross-section is used), the maximum dimensionof the cross-section is intended. Additionally, while primary anchordeployment catheter (500) is depicted as having one lumen (508), in somevariations an anchor deployment catheter may have more than one lumen.As an example, in certain variations, an anchor deployment catheter maycomprise a lumen configured to hold one or more anchors, and anotherlumen configured for delivery of one or more therapeutic agentstherethrough.

Referring now to FIGS. 5B, 5H, and 5I, proximal operating portion (502),which may be used to deploy one or more anchors from primary anchordeployment catheter (500), comprises a handle collar (510) and anactuator (512). Handle collar (510) is fixedly coupled to two slide pins(514) and (516), and actuator (512) is slidably coupled to the slidepins. A compression spring (518) is disposed between handle collar (510)and actuator (512). Compression spring (518) may have a spring constantof, for example, about 0.25 lb/inch to about 1.5 lb/inch, and/or may beformed of, for example, stainless steel. Compression spring (518) iscoaxially disposed about a pushing member (520) that is fixedly coupledto actuator (512) and slidably disposed within an aperture (522) (FIG.5B) of handle collar (510). Pushing member (520), actuator (512), andcompression spring (518) may be formed as a single integral unit, or maybe formed of at least two parts that are then interconnected.

Pushing member (520) passes through a sheath (524) of shaft (504) (FIG.5J), to distal anchor deployment portion (506) of shaft (504). As shownin FIG. 5K, pushing member (520) comprises a distal tip portion (521).Distal tip portion (521) is tapered, such that its cross-sectionaldiameter at its distal end is smaller than its cross-sectional diameterat its proximal end, During use, pushing member (520) may be advancedwithin lumen (508), toward a tubular internal stop (530) (FIG. 5L)disposed within the lumen. Distal tip portion (521) may then be advancedinto the lumen (not shown) of internal stop (530), thereby engaging theinternal stop. The distal tip portion may continue to be advanced intothe lumen of the internal stop, until the tapered shape of the distaltip portion prevents it from being able to move any further distally.Thus, the presence of internal stop (530) prevents pushing member (520)from being advanced too far distally during use. It may also therebyprovide a tactile indication that the advancement of the pushing memberis complete.

As shown in FIG. 5D, internal stop (530) also includes notches (597) fortemporary coupling with an anchor, such as anchor (536). For example,the anchor may be aligned within notches (597), which may be used toorient the anchor for deployment. The anchor may be loosely seatedwithin the notches or may have a tighter fit within the notches. Itshould be understood that while the anchor and the internal stop may betemporarily coupled in this way, the anchor and the internal stopgenerally are separate components, and are not integral with each other.

While pushing member (520) comprises a tapered distal portion (521) thatlimits its distal advancement, in some variations, a pushing member mayalternatively or additionally comprise one or more other features thatmay be used to limit its distal advancement (or even proximalwithdrawal). For example, while not being tapered, a pushing member maystill have a varying cross-sectional dimension (e.g., a varyingcross-sectional diameter) along at least a portion of its length.

As an example, FIG. 5M shows a pushing member (560) comprising anelongated portion (562) and a ring (564) surrounding the elongatedportion. As shown in FIG. 5N, when pushing member (560) is advanced intoa tubular internal stop (566), ring (564) contacts the tubular internalstop, preventing further distal movement by the pushing member. While aring is shown, other configurations that essentially function as ashoulder may alternatively or additionally be used.

As another example, FIG. 5O shows a pushing member (567) comprising afirst elongated member (568) coupled to a second elongated member (570).First elongated member (568) has a cross-sectional diameter (D1) that islarger than the cross-sectional diameter (D2) of second elongated member(570). As shown in FIG. 5P, when pushing member (567) is advanced into atubular internal stop (572), cross-sectional diameter (D2) is smallenough for second elongated member (570) to pass through tubularinternal stop (572). However, cross-sectional diameter (D1) is too largefor first elongated member (568) to be able to pass through tubularinternal stop (572). As a result, tubular internal stop (572) preventspushing member (567) from being advanced any further distally.

As an additional example, FIG. 5Q shows a pushing member (574)comprising an elongated member (576) slidably disposed within a tubularmember (578). Tubular member (578) has an outer diameter (D3), whileelongated member (576) has a smaller cross-sectional diameter (D4).Referring now to FIG. 5R, during use, pushing member (574) may beadvanced toward a tubular internal stop (580), until tubular member(578) contacts tubular internal stop (580) and is prevented from beingadvanced any further distally. However, elongated member (576), with itssmaller cross-sectional diameter (D4), may be able to continue beingadvanced distally through tubular internal stop (580). Elongated member(576) may, for example, be long enough to push an anchor out of ananchor deployment catheter during use, without being so long as toextend out of the anchor deployment catheter.

Other variations of pushing members are also contemplated for use withthe devices described here. For example, in some variations, a pushingmember may comprise one or more shoulders and/or angled regions that maybe used to limit or control distal advancement of the pushing memberduring use. Moreover, in certain variations, a pushing member may notcomprise any features for limiting its distal advancement.

Referring back to FIGS. 5C, 5E-5G, 5J, and 5K, pushing member (520) isalso tubular. Additionally, in some variations, pushing member (520) mayhave a spiral cut (not shown) in its distal end. The spiral cut may, forexample, provide the pushing member with enhanced flexibility,pushability, and/or maneuverability (e.g., thereby enhancing the abilityof the pushing member to be advanced through an aortic arch). In somevariations, pushing member (520) may be in the form of a hypotube havinga spiral cut in its distal end (e.g., formed by a laser). While a spiralcut is described, certain variations of pushing members may include cutswith different configurations. For example, in some variations, apushing member may include slits that are transverse to a longitudinalaxis of the pushing member. In certain variations, a pushing member maycomprise a coiled wire or ribbon at its distal end (e.g., rather than aspiral cut, or in addition to a spiral cut). Moreover, some pushingmembers may include one or more of these features in a differentlocation, either as an alternative to, or in addition to, including thefeatures in their distal ends.

Because pushing member (520) is tubular, one or more coupling membersmay pass through the center of pushing member (520), For example, and asshown in FIG. 5J, a coupling member (as shown, a tether (538)) passesthrough the center of pushing member (520). Pushing member (520)comprises a liner (540) that may be formed of one or more materials thatenhance the advancement of the pushing member along a coupling member.For example, liner (540) may be formed of high-density polyethylene(HDPE) or polytetrafluoroethylene (PTFE), such as etchedpolytetrafluoroethylene, or flattened polyimide. While one variation ofa pushing member has been described, other suitable variations ofpushing members may be used, such as pushing members that do notcomprise liners, that are not spiral cut, and/or that are not tubular.Moreover, in some variations of devices and/or methods, more than onepushing member may be employed. As an example, a device may beconfigured to deploy two anchors simultaneously, and may comprise twopushing members, with one pushing member to be used for each anchor.

Referring again to FIGS. 5B, 5H, and 5I, proximal operating portion(502) also comprises an O-ring housing (526) including an O-ring (527).Tether (538), which is coupled to an anchor (536) and runs through theentirety of primary anchor deployment catheter (500) (as discussed inadditional detail below), passes through O-ring (527). O-ring (527) maybe used to help maintain tension on tether (538), thereby limiting thelikelihood that tether (538) will bunch up during use (e.g., toward thedistal end of primary anchor deployment catheter (500)). O-ring (527)may be made of, for example, silicone, ethylene propylene terpolymerrubber, butyl rubber, polyisoprene, one or more thermoplastic elastomers(e.g., one or more KRATON® thermoplastic elastomers), or a combinationthereof. While primary anchor deployment catheter (500) is described asincluding an O-ring, in some variations, a primary anchor deploymentcatheter may not include an O-ring. Additionally, in certain variations,a secondary anchor deployment catheter may include an O-ring. Moreover,some variations of catheters may include an element that has a differentconfiguration from an O-ring, but that can also be used to maintaintension on a tether.

During use of primary anchor deployment catheter (500), an operator maydepress actuator (512), thereby causing compression of compressionspring (518) and slidable movement of pushing member (520) within lumen(508) of shaft (504). This allows pushing member (520) to contact ananchor disposed within lumen (508) of shaft (504), and push the anchorout of the lumen so that the anchor is deployed into a target site. Itshould be understood that while FIGS. 5A, 5B, 5H, and 5I show actuator(512) as having a particular geometry or shape, any suitable shape maybe used. It may be desirable, however, for actuator (512) to have anergonomic shape, so that it is comfortable for operation by depressionwith a user's thumb, for example. It should also be noted that in somevariations, different actuation mechanisms may alternatively oradditionally be used.

While the mechanism for deploying an anchor distally from the shaftlumen depicted in FIGS. 5C, 5E-5G, and 5K includes a slidable anchor, aspring, and a pushing member slidably disposed within the shaft lumen,any suitable deployment mechanism may be used with the devices, methods,and kits described here. As an example, some variations of anchordeployment devices may not comprise a spring, while other variations ofanchor deployment devices may comprise more than one spring. Moreover,while a pushing member is shown, other appropriate mechanisms may beused, including but not limited to hydraulic mechanisms, pressurized airmechanisms, or any other mechanisms capable of providing an axial forceon an anchor that is sufficient to deploy the anchor distally from alumen of a shaft. Similarly, all or a portion of the anchor may be madefrom, or coated or embedded with, one or more magnetic materials, and acorresponding magnet (e.g., a magnet on the tip of a catheter) may beplaced distally of the anchor to withdraw the anchor from the lumen.Additionally, any suitable component may be used as part of such amechanism (e.g., pistons, plungers, cables, pumps, etc.), and themechanism for deploying the anchor may be made from any suitablematerial or materials, such as one or more metal alloys (e.g., stainlesssteel, nickel titanium alloy), polymers (e.g., nylon,polyetheretherketone (PEEK), polyether block amides,polytetrafluoroethylene (PTFE)), mixtures or combinations thereof, andthe like. In one variation, the mechanism for deploying the anchor maycomprise a pushing member made of stainless steel and coated at least inpart with polytetrafluoroethylene, which may help to reduce frictionwhen sliding within the lumen of the catheter shaft.

The mechanism for deploying anchors may also be reinforced along thosesections that do not traverse curves within the device shaft (e.g., inthe case of a pushing member, the pushing member may be reinforced alongits straight length). The mechanism may be reinforced with any suitablematerial or materials. As an example, in some variations, a metal orpolymer tubing may be used, such as a metal hypotube. Similarly, thedistal end of the mechanism may be reinforced with an element that helpsto impart the axial force transmitted from the actuation onto thecollapsed anchor.

Referring now to FIGS. 5A, 5C-5G, 5K, and 5L, distal anchor deploymentportion (506) of shaft (504) is the location from which one or moreanchors may be deployed. As shown, distal anchor deployment portion(506) includes a curved region (528) (FIG. 5A), as well as an inflectionpoint (529) (FIGS. 5C and 5G). In some variations, distal anchordeployment portion (506) may further comprise one or more additionalcurves. For example, distal anchor deployment portion (506) may compriseanother curved region (571) (FIGS. 5E and 5G) that is distal toinflection point (529). Curved region (571) may, for example, curve awayfrom external stop (532), which is described in further detail below.

The curvature of an anchor deployment device may depend, for example, onthe characteristics of the target anatomy. Having at least one preformedcurve near the distal end of the shaft may help a catheter to accessareas that may otherwise be difficult to reach. For example, curvedregion (528) and/or curved region (571) may help primary anchordeployment catheter (500) to point toward tissue and/or to contacttissue upon exiting through an opening in a guide tunnel, and/or topoint away from the guide tunnel. Inflection point (529) may also helpto position the distal end of primary anchor deployment catheter (500)with respect to tissue. Curved region (528) forms an arc that may haveany suitable or desirable central angle. For example, the central anglemay be from about 15 degrees to about 270 degrees, from about 45 degreesto about 180 degrees, or from about 50 degrees to about 120 degrees. Itshould be noted that some variations of anchor deployment devices maynot include any curved regions or inflection points, or may includemultiple (i.e., at least two) curved regions and/or inflection points.Variations of curved anchor deployment devices are discussed inadditional detail below.

In some variations in which the flexible percutaneous devices describedhere are used in the repair of a heart valve (e.g., a mitral valve), andparticularly when the valve is approached subannularly, the cathetershaft may have a radius of curvature that is larger than that of theannulus of the valve. In this way, when the catheter is situated in thesubannular groove, the tip of the catheter may point outward against theannulus and the ventricular wall. In certain variations, the tip of thecatheter may be beveled. For example, the tip may have one or morediagonal cuts and/or other various shapes on its edge, rather thanhaving a square-cut edge. This may, for example, help to direct theanchors outward upon deployment. Of course, some variations of anchordeployment catheters may include tips without any beveling (e.g., havinga square-cut edge).

As shown in FIGS. 5C-5G, 5K, and 5L, distal anchor deployment portion(506) includes sheath (524), internal stop (530) disposed within sheath(524), and an external stop (532). Distal anchor deployment portion(506) also comprises the distal tip (534) of primary anchor deploymentcatheter (500). External stop (532) is coupled to (e.g., welded to) orintegral with internal stop (530), and extends through an opening (notshown) in sheath (524), The opening in the sheath may have anyappropriate size and configuration. For example, the opening may becircular or oval, or may be in the form of a slot. External stop (532)is in the form of an elongated flap and may, for example, have a widthof about 0.05 inch to about 0.2 inch (e.g., about 0.08 inch), and/or alength of about 0.1 inch to about 0.3 inch (e.g., about 0.2 inch).

Internal stop (530) and/or external stop (532) may be made from, forexample, one or more metal alloys (e.g., stainless steel and/orNitinol), and/or one or more polymers (e.g., PEBAX® 7233 polymer). Theinternal and external stops may be made of the same material ormaterials, or may be made of different materials. In some variations,the internal and/or external stops may be laser-cut. While external stop(532) is coupled to or integral with internal stop (530), in somevariations, an external stop may not be coupled to or integral with aninternal stop. For example, an external stop may be formed of a piece ofmaterial (e.g., a polymer) that is formed separately from an anchordeployment catheter and then is thermally fused to the outer surface ofthe anchor deployment catheter. Additionally, while an anchor deploymentcatheter including one internal stop and one external stop is shown,some variations of anchor deployment catheters may not comprise aninternal stop and/or may not comprise an external stop. Moreover,certain variations of anchor deployment catheters may comprise multipleinternal stops and/or external stops.

During use, as anchor (536) is being deployed from primary anchordeployment catheter (500), internal stop (530) helps to prevent pushingmember (520) from being pushed too far distally. More specifically, andas described above, as pushing member (520) is pushed distally, distaltip portion (521) enters the lumen of internal stop (530). Distal tipportion (521) may be tapered, such that its proximal end has a largercross-section than its distal end. This tapering may be configured sothat at a certain point, the cross-sectional size of the distal tipportion is too large to fit within the lumen of the tubular internalstop. As a result, the pushing member cannot be advanced any furtherdistally.

Additionally, external stop (532) may function to prevent primary anchordeployment catheter (500) from being over-advanced through an opening ina guide tunnel during the anchor deployment process. This, in turn, mayhelp to limit the likelihood of damage to the target site during use ofthe anchor deployment catheter. For example, FIG. 5S shows distal anchordeployment portion (506) of primary anchor deployment catheter (500)being advanced through an opening (586) in a wall portion (588) of aguide tunnel (590). As distal anchor deployment portion (506) isadvanced through opening (586), external stop (532) remains within thelumen (591) of the guide tunnel. External stop (532) bends back asdistal anchor deployment portion (506) continues to be advanced. At acertain point, distal anchor deployment portion (506) will not be ableto be advanced any further. This may occur, for example, becauseexternal stop (532) is not able to bend back any more, and/or becausewall portion (588) of guide tunnel (590) becomes wedged between externalstop (532) and sheath (524) (as shown in FIG. 5S). Thus, external stop(532) may help prevent primary anchor deployment catheter (500) frombeing inadvertently advanced too far out of guide tunnel (590).

While one variation of an external stop has been shown, other suitablevariations of external stops may alternatively or additionally be used.In some variations, an external stop may be relatively straight, whilein other variations, an external stop may include one or more curves(e.g., to promote smooth tracking of the catheter or device of which theexternal stop is a part). In certain variations, an external stop mayhave a curvature that is designed to correspond with the curvature ofthe target site.

FIG. 5T depicts another variation of an external stop. As shown there, adistal portion (592) of an anchor deployment catheter (593) is advancedthrough an opening (594) in a wall portion (595) of a guide tunnel(596). Anchor deployment catheter (593) comprises an elongated member(599) and an external stop (598). As distal portion (592) of anchordeployment catheter (593) is advanced through opening (594), externalstop (598) bends back from elongated member (599). Eventually, theexternal stop will prevent the anchor deployment catheter from beingadvanced any further distally within the guide tunnel. Although externalstop (598) is similar to external stop (532) shown above, it is orienteddifferently with respect to the opening in the guide tunnel during use.Moreover, as shown in FIG. 5T, external stop (598) functions primarilyby bending backward until it can bend no further. External stop (532)(FIG. 5S), on the other hand, may function by bending backward until itcan bend no further, and/or by providing a location (between theexternal stop and the wall or sheath of the anchor deployment catheter)in which the guide tunnel wall can become wedged. In some variations,external stop (598) may be formed of, for example, a flat ribbon, suchas a Nitinol flat ribbon. While not shown here, other variations ofdevices may comprise internal and/or external stops comprising one ormore flat ribbons.

External stops may have any suitable size, shape, and configuration. Insome variations, an external stop may be integrally formed or fixedlycoupled to another component of a catheter or other device. For example,an external stop may be integral with, or fixedly coupled to, aninternal stop, and/or one or more other components of a catheter. FIG.5U shows a variation of a catheter (501) comprising an external stop(503) in the form of an elongated wire loop form (e.g., comprisingNitinol). As shown, a portion of external stop (503) is disposed withina lumen (507) of catheter (501), while the loop portion of external stop(503) extends externally of catheter (501). However, in some variations,an external stop comprising a wire form may include different portionsthat are internally or externally located relative to a catheter body.In certain variations, an external stop may even be completely externalto a catheter body. External stop (503) comprises a hinge region (509)that allows external stop (503) to bend or move (e.g., when compressedagainst an inner wall of a catheter during use), As shown, external stop(503) is coupled to catheter (501) by a ring (505) (e.g., formed of oneor more metals and/or metal alloys). However, an external stop may becoupled to a catheter body in other ways. As an example, a polymersleeve (e.g., formed of 55D PEBAX® polymer) may be used to attach anexternal stop to a catheter body. As another example, an external stopmay be welded to a connecting member, and the resulting assembly may bebonded to the catheter body.

Still other variations of external stops may be used. For example, andas shown in FIG. 5V, in certain variations, an external stop (511) of acatheter (513) may comprise a leaf spring (515) (e.g., formed ofstainless steel). In some variations, leaf spring (515) may have athickness of about 0.01 inch. Leaf spring (515) has a rounded distal end(517) that may be formed, for example, by heating and molding leafspring (515). Rounded distal end (517) may, for example, be relativelyunlikely to cause damage to a guide tunnel or other device during use.It should be noted, of course, that other variations of external stopsmay be configured differently. For example, in some variations, anexternal stop may have a rounded end, but may not comprise a leafspring, or an external stop may not have a rounded end. Additionalnon-limiting examples of external stops are shown in FIGS. 5W and 5X. InFIG. 5W, a catheter (531) comprises an external stop (533) in the formof a molded appendage or thumb protruding from the outer surface (539)of the catheter. Similarly, FIG. 5X shows a catheter (535) comprising anexternal stop (537) in the form of a protrusion extending from the outersurface (541) of the catheter.

Other appropriate internal or external stop configurations may also beused. As an example, in some variations, a catheter may comprise one ormore wire formations that may function as external stops, and that aredifferent from the elongated wire loop form depicted in FIG. 5U above.As another example, certain variations of catheters may compriseinternal and/or external wings and/or bumps that may help to control theadvancement of the catheters (e.g., relative to other catheters). Somevariations of stops may function to slow or temporarily stop theadvancement of a device. This may allow the operator an opportunity todetermine whether to continue to advance the device. For example, incertain variations, a device may comprise one or more stops thatessentially function as “speed bumps,” providing resistance and therebyslowing the advancement of the device. This may, for example, providethe operator with a signal that it may be desirable to stop advancingthe device. In some variations, the stops may comprise a round portionfollowed by a flattened portion, where the round portion is configuredto initially provide resistance to further advancement of the device. Ifthe operator continues to advance the device despite the resistance,then the flattened portion may allow for a normal rate of advancement toresume. In some variations, a catheter may comprise one or morevisor-shaped stops that may be designed, for example, to provideincreasing resistance as the catheter continues to be advanced.

External stops may be located in any suitable location of a device. Insome variations, an anchor deployment catheter may comprise one or moreexternal stops that are coupled to its distal end. As an example, acatheter may comprise a spring cone at its distal end that providestactile feedback to the operator as to the location of the device. Asanother example, a device may comprise one or more friction-generatingmaterials (e.g., a latex film) in one or more locations that areselected to result in increased resistance to device advancement whencontacted. As an additional example, a catheter may comprise anexpandable collar in its distal portion that may limit or preventadvancement of the catheter once expanded.

Additional non-limiting examples of stops include petals that areconfigured to anchor at the side of the myocardium during a heart valverepair procedure and then to retract after at least one anchor has beendeployed. The surface area and/or rigidity of the petals may be selectedto prevent them from permanently penetrating into the myocardium.

In some variations, a device may comprise a catheter and a sheathsurrounding at least a portion of the catheter, Where the portionincludes a distal portion of the catheter. The sheath may be slidablewith respect to the catheter, while also being fixed to the catheter ina distal portion of the device. During use, the device may be positionedsuch that the catheter and sheath contact a tissue surface. As thedevice is pressed against the tissue surface, the sheath may becomelamer in diameter (e.g., like an umbrella), and may effectively preventor limit any further movement toward or into the tissue by the catheter.In this way, the sheath may function as a stop element for the device.

While the external stops shown above are depicted as helping to controlthe advancement of a primary anchor deployment catheter through anopening in a wall portion of a guide tunnel, external stops may be usedwith any of a number of different devices or combinations of devices. Asan example, in some variations, a secondary anchor deployment cathetermay comprise one or more external stops (e.g., to control itsadvancement through an opening in a wall portion of a guide tunnel). Asanother example, in certain variations, a catheter that is not an anchordeployment catheter may comprise one or more external stops. As anadditional example, a device comprising one or more external stops maybe advanced out of another device that is not a guide tunnel.

As depicted in FIGS. 5C-5G, 5K, and 5L, anchor (536) has been loadedinto lumen (508) of shaft (504). Tether (538) is coupled to anchor(536), and extends proximally through primary anchor deployment catheter(500), exiting at the proximal end of proximal operating portion (502).For example, FIG. 5J shows a cross-sectional view of a region of shaft(504) that is substantially proximal to distal anchor deployment portion(506), and that includes sheath (524), pushing member (520), and tether(538).

Generally, a primary anchor deployment catheter will include at leastone tether that is fixedly coupled to the anchor that is being deployed.Thus, deployment of the anchor also may result in deployment of thetether. As an example, tether (538) of primary anchor deploymentcatheter (500) may be fixedly coupled to anchor (536), For example, thetether may be knotted around an eyelet in the anchor, or in variationsin which the tether comprises multiple filaments, the anchor may bethreaded through the filaments. In some variations, a tether may befused around an anchor and/or to an anchor by applying heat to thetether and/or anchor. For example, the tether may comprise multiplebraided strands, and the free ends of the strands may be heat-fusedtogether around the anchor (e.g., after the anchor has been insertedbetween the strands). This may, for example, provide for a strongtether-anchor coupling that may be formed in a relatively controlledfashion (e.g., such that the remaining length of tether is neither tooshort nor too long). In certain variations, a tether may be knotted orotherwise tied to an anchor, and the resulting coupling may be heated toweld or fuse different parts of the tether together (e.g., therebyenhancing the security of the coupling). For example, a tether may besecured to an anchor using one or more knots (e.g., overhand knots,double-overhand knots, bowline knots, figure-of-eight knots, Ashleyknots, etc.). Alternatively or additionally; a tether may be secured toan anchor using one or more splices (e.g., back splices, eye splices),which may be relatively space-efficient, may be self-locking, and/or mayresult in relatively little stress on the tether. Heat and/orcompression may be applied to the knots and/or splices after formation.In certain variations, a tether may be coupled to an anchor using one ormore adhesives. Other appropriate coupling mechanisms may alternativelyor additionally be used. Additional examples of coupling mechanisms aredescribed, for example, in U.S. Provisional Application Ser. Nos.61/083,109, filed on Jul. 23, 2008, and 61/160,018, filed on Mar. 13,2009, and in U.S. patent application Ser. No. 12/505,332, filed on Jul.17, 2009, all of which are hereby incorporated by reference in theirentirety.

While not shown, in some variations, an anchor deployment catheter maycomprise at least one ring in its distal anchor deployment portion. Thering may provide enhanced structural stability to the distal deploymentportion, and may be located, for example, between an internal stop inthe catheter and the distal tip of the catheter. In some variations, thering may surround a sheath of the catheter, and may be in the form of ahypotube. Other reinforcement structures may alternatively oradditionally be used, as appropriate.

Referring specifically now to FIG. 5H, shaft (504) of primary anchordeployment catheter (500) may generally be selected to have a lengthsuitable for accessing the desired target site. As shown there, shaft(504) includes a proximal shaft region (550), a mid-shaft region (552),a first intermediate shaft region (554), a second intermediate shaftregion (556), and a distal shaft region (557). Proximal shaft region(550) may be relatively long depending, for example, on the application.In some variations (e.g., some variations in which primary anchordeployment catheter (500) has to traverse a relatively long path toreach a target site), proximal shaft region (550) may have an extendedlength of about 100 centimeters to about 145 centimeters (e.g., about110 centimeters to about 125 centimeters, such as about 118centimeters), Where the “extended length” refers to the length of theregion when straight. In certain variations (e.g., certain variations inwhich primary anchor deployment catheter (500) has to traverse a shorterpath to reach a target site, such as certain variations in which theprimary anchor deployment catheter enters the body via the groin),proximal shaft region (550) may have an extended length of about 10centimeters to about 40 centimeters (e.g., about 20 centimeters to about30 centimeters, such as about 25 centimeters).

In some variations, mid-shaft region (552) may have an extended lengthof about 5 centimeters to about 30 centimeters (e.g., about 10centimeters to about 25 centimeters, such as about 17 centimeters),first intermediate shaft region (554) may have an extended length ofabout 3 centimeters to about 10 centimeters (e.g., about 3 centimetersto about 7 centimeters, such as about 5 centimeters), secondintermediate shaft region (556) may have an extended length of about 1centimeter to about 5 centimeters about 1 centimeter to about 3centimeters, such as about 2 centimeters), and/or distal shaft region(557) may have an extended length of about 1 millimeter to about 10millimeters (e.g., about 1 millimeter to about 6 millimeters, such asabout 3 millimeters). In certain variations, such as when a primaryanchor deployment catheter is configured for percutaneous use, the shaftof the primary anchor deployment catheter may have an overall extendedlength of about 110 centimeters to about 190 centimeters (e.g., about120 centimeters to about 180 centimeters, or about 130 centimeters toabout 160 centimeters, such as about 145 centimeters). Of course,primary anchor deployment catheter (500) is only one exemplary variationof an anchor deployment catheter, and other variations of anchordeployment catheters or other types of catheters may have differentconfigurations. As an example, a catheter may comprise a shaft having adifferent number of regions having different lengths, or may evencomprise a uniform construction along the entirety of its length. Anysuitable catheter configuration may be employed.

Each of the regions of shaft (504) shown in FIG. 5H may be formed of thesame material or materials, or some or all of the regions may be formedof different materials. For example, it may be desirable for a moreproximal region, such as proximal shaft region (550), to be formed ofone or more relatively stiff materials (e.g., for enhanced pushability),while a more distal region, such as second intermediate region (556) ordistal shaft region (557), is formed of one or more relatively flexiblematerials (e.g., for maneuverability).

Examples of materials which may be suitable for any or all of theregions or components of a catheter or other device include polymers,such as polyether-block co-polyamide polymers (e.g., PEBAX® polyetherblock amide copolymer), copolyester elastomers, thermoset polymers,polyolefins (e.g., polypropylene or polyethylene, including high-densitypolyethylene (HDPE) and low-density polyethylene (LDPE)),polytetrafluoroethylene (e.g., TEFLON™ polymer) or other fluorinatedpolymers, ethylene vinyl acetate copolymers, polyamides, polyimides,polyurethanes (e.g., PGLYBLEND™ polymer), polyvinyl chloride (PVC),fluoropolymers (e.g., fluorinated ethylene propylene (FEP),perfluoroalkoxy (PFA) polymer, polyvinylidenefluoride (PVDF), etc.),polyetheretherketones (PEEKs), silicones, and copolymers and blendsthereof. Examples of polyamides include Nylon 6 (e.g., ZYTEL® HTN highperformance polyamides from DuPont™), Nylon 11 (e.g., RILSAN® Bpolyamides from Arkema Inc.), and Nylon 12 (e.g., GRILAMID® polyamidesfrom EMS-Grivory, RILSAN® A polyamides from Arkema Inc., and VESTAMID®polyamides from Degussa Corp.).

In certain variations, a catheter or other device may comprise one ormore reinforced polymers. For example, a catheter may comprise one ormore polymers reinforced with one or more metals and/or metal alloys(e.g., stainless steel or a shape memory metal such Nitinol). Polymersmay also be reinforced with textile and/or metal meshes, braids, and/orfibers. In some variations, a catheter may comprise one or more polymercomposites comprising one or more particulate or fibrous fillers. Whencomposites are used, the fillers may be selected to impart a variety ofphysical properties, such as toughness, stiffness, density, and/orradiopacity.

In some variations, a catheter or other device may be formed of multiplepolymers. As an example, in certain variations, an anchor deploymentcatheter may be formed of a blend of different polymers, such as a blendof high-density polyethylene and low-density polyethylene. As anotherexample, an anchor deployment catheter may be formed of differentpolymers having different durometers. For example, a catheter mayinclude different durometer polymers along its length. In certainvariations, a catheter may comprise a first section comprising VESTAMID®polymer, a second section comprising a blend of PEBAX® polymer andVESTAMID® polymer (e.g., 70% PEBAX® polymer and 30% VESTAMID® polymer),a third section comprising a blend of PEBAX® polymer and VESTAMID®polymer (e.g., 90% PEBAX® polymer and 10% VESTAMID® polymer), and/or afourth section comprising 100% PEBAX® polymer. Of course, other suitablematerials may also be used. In some variations, the first section mayhave an extended length of about 5 centimeters to about 30 centimeters(e.g., about 10 centimeters to about 25 centimeters, such as about 17centimeters), the second section may have an extended length of about 3centimeters to about 10 centimeters (e.g., about 3 centimeters to about7 centimeters, such as about 5 centimeters), the third section may havean extended length of about 1 centimeter to about 5 centimeters (e.g.,about 1 centimeter to about 3 centimeters, such as about 2 centimeters),and/or the fourth section may have an extended length of about 1millimeter to about 10 millimeters (e.g., about 1 millimeter to about 6millimeters, such as about 3 millimeters), In certain variations, acatheter may include a fifth, proximal-most section comprising, forexample, GRILAMID® polymer. In some variations, such as some variationsin which the catheter needs to traverse a relatively long percutaneouspath to reach a target site, the fifth section may have an extendedlength of, for example, about 100 centimeters to about 145 centimeters(e.g., about 110 centimeters to about 125 centimeters, such as about 118centimeters). In certain variations, such as certain variations in whichthe catheter needs to traverse a relatively short percutaneous path toreach a target site, the fifth section may have an extended length of,for example, about 10 centimeters to about 40 centimeters (e.g., about20 centimeters to about 30 centimeters, such as about 25 centimeters).

While the wall of a catheter may be formed of a single layer, somevariations of catheters may include walls having multiple layers (e.g.,two layers, three layers). For example, a catheter may comprise an outercatheter wall comprising one or more flexible polymers and an innerreinforcing wall formed, for example, from a braided or woven mesh(e.g., a polymer or metal braided or woven mesh). The inner reinforcingwall may help to provide stiffness to selected regions of the catheter.Some variations of catheters may include at least two sections that areformed of different materials and/or that include different numbers oflayers. Additionally, certain variations of catheters may includemultiple (e.g., two, three) lumens. The lumens or walls may, forexample, be lined and/or reinforced (e.g., with braiding or winding).The reinforcing structures, if any, may be metallic or may comprise oneor more non-metals or polymers having a higher durometer.

As shown in FIG. 5H, shaft (504) also comprises a strain relief region(558). Strain relief region (558) may, for example, prevent high strainin the area between the port (555) of proximal operating portion (502)and shaft (504). This, in turn, may decrease the likelihood of breakageoccurring in this area. In certain variations, strain relief region(558) may provide additional support (e.g., increasing the overallmaneuverability of the catheter). In some variations, strain reliefregion (558) may be in the form of a shrink tube with a friction fit, ora metal and/or coil structure. In certain variations, strain reliefregion (558) may be in the form of an extra polymer layer over shaft(504). The extra polymer layer may or may not chemically bond to theshaft. In some variations, the extra polymer layer may comprise 100%PEBAX® polymer, or may comprise a mixture of polymers, such as a mixtureof a PEBAX® polymer with one or more other polymers.

As described above, in some variations, after a primary anchordeployment catheter has been used to deploy an anchor that is fixedlycoupled to a tether, one or more secondary anchor deployment cathetersmay be used to deploy one or more additional anchors over the tether.The additional anchors may, for example, be slidably deployed over thetether.

FIGS. 6A-6N provide an illustrative depiction of a variation of asecondary anchor deployment catheter (600). First, and referringspecifically to FIGS. 6A-6I, secondary anchor deployment catheter (600)comprises a proximal operating portion (602) and an elongated shaft(604) including a distal anchor deployment portion (606). Shaft (604)defines a lumen (608) (FIG. 6E), and a mechanism for deploying an anchordistally from the lumen, described in further detail below.

Referring now to FIGS. 6B-6D, 6J, and 6K, proximal operating portion(602), which may be used to deploy one or more anchors from secondaryanchor deployment catheter (600), comprises a handle collar (610) and anactuator (612). Handle collar (610) is fixedly coupled to two slide pins(614) and (616), and actuator (612) is slidably coupled to the slidepins. A compression spring (618) is disposed between handle collar (610)and actuator (612). Compression spring (618) is coaxially disposed abouta pushing member (620) that is fixedly coupled to actuator (612) andslidably disposed within an aperture (622) (FIG. 6C) of handle collar(610). It should be noted that features described above with respect tocompression spring (518), such as the spring constant, may also beapplied to compression spring (618), as appropriate. Pushing member(620), actuator (612), and compression spring (618) may be formed as asingle integral unit, or may be formed of at least two parts that arethen interconnected.

Pushing member (620) passes through a sheath (624) of shaft (604) (FIG.6L), to distal anchor deployment portion (606) of shaft (604). As shownin FIG. 6E, pushing member (620) comprises a tapered distal tip portion(621) that may be advanced into a tubular internal stop (632) located inlumen (608) of secondary anchor deployment catheter (600). Internal stop(632) prevents over-advancement of the pushing member during deployment,as described above with reference to primary anchor deployment catheter(500). It should be noted that while a tapered distal tip portion isdescribed, other variations of secondary anchor deployment catheters maycomprise pushing members with different configurations, such as one ormore of the pushing members described above with reference to FIGS.5M-5R. Internal stop (632) comprises notches (697) (FIG. 6F) that helpto hold an anchor (e.g., anchor (636), as shown) in place prior todeployment.

Pushing member (620) is tubular and comprises a liner (640) (FIG. 6L).Liner (640) may, for example, be made of one or more materials thatenhance the slidability of the pushing member over a coupling member. Insome variations, pushing member (620) may be in the form of a laser-cuthypotube, although other suitable variations may alternatively be used.A retrieval tether (637) (FIG. 6L) passes through pushing member (620),and will be described in additional detail below. While one variation ofa pushing member has been described, other variations of pushing membersmay be used in secondary anchor deployment catheters, as appropriate.

During an anchor deployment procedure, a tether may be threaded intolumen (608) of shaft (604), and may be coupled to an anchor (e.g.,anchor (636), shown in FIGS. 6E-6I and 6N). For example, the tether maybe coupled to the anchor by being threaded through an eyelet of theanchor. In some variations, a tether may be threaded through arelatively small portion of lumen (608) of shaft (604). As an example,in certain variations, a tether may be threaded only through a portionof lumen (608) in distal anchor deployment portion (606). For example,FIG. 6O shows a tether (660) threaded through openings (662) and (664)in distal anchor deployment portion (606). Tether (660) crosses a shortsection of lumen (608), passing through the eyelet of anchor (636). Ofcourse, the routing shown in FIG. 6O is only one variation of a tetherrouting, and tethers may be routed through a catheter in any appropriatemanner.

After the tether has been coupled to the anchor, the anchor may bedeployed over the tether. An operator may depress actuator (612),thereby causing compression of compression spring (618) and slidablemovement of pushing member (620) axially within lumen (608) of shaft(604). This allows pushing member (620) to contact anchor (636) and pushthe anchor out of the lumen, thereby deploying the anchor into a targetsite. Internal stop (632) prevents pushing member (620) from beingpushed too far distally. Thus, the pushing member may be pushed asufficient amount to deploy anchor (636), without being pushed out ofshaft (604). In some variations, internal stop (632) may be radiopaque.This may, for example, allow internal stop (632) to be aligned with acorresponding radiopaque band or marker on a guide tunnel when secondaryanchor deployment catheter (600) is being advanced through the guidetunnel. Such alignment may be used to control the advancement of thesecondary anchor deployment catheter through the guide tunnel.

Referring now to FIGS. 6A, 6E-6I, 6M, and 6N, distal anchor deploymentportion (606) of shaft (604) is the location from which one or moreanchors may be deployed. As shown, distal anchor deployment portion(606) includes a curved region (628) (FIG. 6A). Curved region (628)forms an arc that may have any suitable or desirable central angle. Forexample, the central angle may be from about 15 degrees to about 270degrees, from about 45 degrees to about 1.80 degrees, or from about 50degrees to about 120 degrees. As also depicted in FIG. 6E, distal anchordeployment portion (606) includes an inflection point (699). The curvedregion and inflection point may allow for enhanced positioning of theanchor deployment portion. Of course, while not shown, a secondaryanchor deployment catheter or another type of catheter may also comprisemore than one curved region and/or inflection point, or may not compriseany curved regions or inflection points. The curved region(s) and/orinflection point(s) in a catheter may be located in any appropriateregion of the catheter.

Distal anchor deployment portion (606) includes sheath (624) andinternal stop (632), and also comprises the distal tip (634) ofsecondary anchor deployment catheter (600). Additionally, and as shown,distal anchor deployment portion (606) may comprise a spiral-cut tubularmember (630) disposed within sheath (624). Spiral-cut tubular member(630) may help to limit or prevent kinking in distal anchor deploymentportion (606), and may be formed of, for example, one or more metalalloys, such as stainless steel. While a spiral-cut tubular member isshown, in some variations, a tubular member having a differentconfiguration may be used. As an example, a tubular member having asawtooth cut may be used. As another example, reinforcement rings (e.g.,that are transverse to a longitudinal axis of the distal anchordeployment portion) and/or longitudinal reinforcement wires and/orribbon may be used. As a further example, in some variations, a distalanchor deployment portion may comprise a tubular member with transverseslits. Additionally, it should be noted that while spiral-cut tubularmember (630) is depicted as a component of secondary anchor deploymentcatheter (600), other types of catheters may include a spiral-cuttubular member or similar feature, as appropriate.

As depicted in FIGS. 6E-6I and 6N, anchor (636) has been loaded intolumen (608) of shaft (604), such that it is positioned within spiral-cuttubular member (630). Spiral-cut tubular member (630) may, for example,provide protection to anchor (636) prior to deployment. A tether maythen be slidably coupled to anchor (636), as described above.Additionally, retrieval tether (637) is coupled to anchor (636), andextends proximally through secondary anchor deployment catheter (600),exiting at the proximal end of proximal operating portion (602). Asshown, the retrieval tether is looped through an eyelet of the anchor.Retrieval tether (637) may be used, for example, to retrieve anchor(636) if anchor (636) has been deployed incorrectly (e.g., to anon-target site). More specifically, pulling the two strands of theretrieval tether proximally may cause the anchor to be pulledproximally, as well, and to thereby re-enter the lumen of the secondaryanchor deployment catheter. The retrieval tether is also, of course,capable of being disengaged from the anchor after appropriate placementof the anchor. In some variations, the retrieval tether may bedisengaged from the anchor by pulling on a proximal end of a singlestrand of the retrieval tether and withdrawing the retrieval tether fromthe anchor eyelet and the catheter. Retrieval tether (637) may be formedof any of the coupling member materials described herein, asappropriate. Furthermore, while a secondary anchor deployment catheterincluding a single retrieval tether has been described, in somevariations, a secondary anchor deployment catheter may include multipleretrieval tethers, or may not include a retrieval tether at allAdditional anchor retrieval mechanisms are described below.

As shown in FIGS. 6B-6D, proximal operating portion (602) of secondaryanchor deployment catheter (600) comprises a locking mechanism (626)that may be used to tension retrieval tether (637). This may, forexample, limit the likelihood of retrieval tether (637) experiencingundesirable bunching and/or excessive slackness during use of secondaryanchor deployment catheter (600). Locking mechanism (626) may beadjusted either to apply tension to retrieval tether (637), or not toapply tension to retrieval tether (637). While secondary anchordeployment catheter (600) includes locking mechanism (626), in somevariations, a secondary anchor deployment catheter may alternatively oradditionally include one or more other tether-tensioning components(e.g., an O-ring). Moreover, in certain variations, a primary anchordeployment catheter or another type of catheter may include a lockingmechanism. In some variations, a catheter, such as an anchor deploymentcatheter, may not include any tether-tensioning components.

Referring now to FIGS. 6E-6I and 6N, distal tip (634) of distal anchordeployment portion (606) includes notches (672) and (674), as well as atether-routing slot (675). Notches (672) and (674), and/ortether-routing slot (675), may, for example, be cut (e.g., laser-cut) ormolded into the distal tip. Moreover, while two notches are shown, somevariations of catheters may comprise just one notch or more than twonotches, or may not comprise any notches. Similarly, certain variationsof catheters may comprise more than one tether-routing slot, or may notcomprise any tether-routing slots. Additionally, notches andtether-routing slots or other openings may have different shapes fromthose shown, and the notches or tether-routing slots on a catheter mayall have the same shape, or may have different shapes.

Notches (672) and (674) may be used, for example, to help align andorient anchor (636) during deployment and/or for retrieval. For example,immediately after anchor (636) has been deployed from distal anchordeployment portion (606), the proximal portion of anchor (636) may beseated in notches (672) and (674). The operator may then choose towithdraw the catheter, thereby leaving the anchor behind or, if theanchor has been deployed incorrectly (e.g., to a non-target site), theoperator may withdraw the anchor back into the catheter (e.g., using theretrieval tether). The positioning of the proximal portion of the anchorin the notches of the distal tip may make it relatively easy to withdrawthe anchor back into the catheter. Moreover, the positioning of theproximal portion of the anchor in the notches may help to maintain adesired orientation and alignment of the anchor for futurere-deployment.

Tether-routing slot (675) may be used, for example, to help load andposition a tether within secondary anchor deployment catheter (600)(e.g., so that the tether can be coupled to an anchor within thecatheter, such as anchor (636)).

Referring specifically now to FIG. 6J, shaft (604) of secondary anchordeployment catheter (600) generally has a length selected for accessingthe desired target site, and includes a proximal shaft region (650), amid-shaft region (652), a first intermediate shaft region (655), asecond intermediate shaft region (656), and a distal shaft region (657).In some variations, proximal shaft region (650) may be relatively long(e.g., depending on the application). In certain variations (e.g.,certain variations in which secondary anchor deployment catheter (600)has to traverse a relatively long path to reach a target site), proximalshaft region (650) may have an extended length of about 100 centimetersto about 145 centimeters (e.g., about 110 centimeters to about 125centimeters, such as about 118 centimeters). In some variations (e.g.,some variations in which secondary anchor deployment catheter (600) hasto traverse a shorter path to reach a target site, such as certainvariations in which the secondary anchor deployment catheter enters thebody via the groin), proximal shaft region (650) may have an extendedlength of about 10 centimeters to about 40 centimeters (e.g., about 20centimeters to about 30 centimeters, such as about 25 centimeters).

In some variations, mid-shaft region (652) may have an extended lengthof about 5 centimeters to about 30 centimeters (e.g., about 10centimeters to about 25 centimeters, such as about 17 centimeters),first intermediate shaft region (655) may have an extended length ofabout 3 centimeters to about 10 centimeters (e.g., about 3 centimetersto about 7 centimeters, such as about 5 centimeters), secondintermediate shaft region (656) may have an extended length of about 1centimeter to about 5 centimeters (e.g., about 1 centimeter to about 3centimeters, such as about 2 centimeters), and/or distal shaft region(657) may have an extended length of about 1 millimeter to about 10millimeters (e.g., about 1 millimeter to about 6 millimeters, such asabout 3 millimeters).

Each of the regions of shaft (604) shown in FIG. 6J may be formed of thesame material or materials, or some or all of the regions may be formedof different materials. For example, it may be desirable for a moreproximal region (e.g., proximal shaft region (650)) to be formed of oneor more relatively stiff materials (e.g., for enhanced pushability),while a more distal region (e.g., second intermediate shaft region (656)and/or distal shaft region (657)) is formed of one or more relativelyflexible materials (e.g., for maneuverability). Examples of materialswhich may be suitable for any or all of these regions include thoseprovided above with reference to primary anchor deployment catheter(500), as well as any other appropriate materials.

As shown in FIG. 6J, shaft (604) also comprises a strain relief region(658). Strain relief region (658) may, for example, have one or more ofthe features and/or advantages of strain relief region (558) of primaryanchor deployment catheter (500), described above.

As described above, in some variations, the shaft of an anchordeployment catheter may be relatively flexible (e.g., for use inpercutaneous procedures). In some cases in which an anchor deploymentcatheter is intended for use in percutaneous procedures, the anchordeployment catheter may comprise a shaft that is longer than it would bein cases in which an anchor deployment catheter is intended for use insurgical procedures. Any suitable material or materials may be used toconstruct a catheter shaft to render the shaft relatively flexible. Forexample, the flexible shaft may be made of one or more polymers (e.g.,nylon, polyethylene, polyetheretherketone (PEEK), polyether blockamides, polytetrafluoroethylene (PTFE), fluorinated ethylene propylenecopolymer), one or more polymer blends (e.g., nylon blends), one or moremetal alloys (e.g., nickel titanium alloys, stainless steel), orcombinations thereof.

As described above, in some variations, an anchor deployment cathetermay comprise one or more relatively rigid materials. Such a device maybe particularly useful, for example, in surgical applications, where anincision is used to access the site for anchor deployment. Any suitablerigid material or materials may be used. For example, the catheter maycomprise a shaft that is made from one or more metal alloys (e.g.,stainless steel, nickel titanium alloys), one or more polymer composites(e.g., carbon-filled nylon, carbon-filled polyetheretherketone), one ormore polymers (e.g., polypropylene, high density polyethylene), orcombinations thereof.

While secondary anchor deployment catheter (600) is depicted as having acertain configuration, it should be noted that other secondary anchordeployment catheters may have different configurations depending, forexample, on the characteristics of the target site and/or thepreferences of the operator.

As discussed above, certain variations of anchor deployment cathetersmay comprise shafts having one or more curves. The curve or curves in acatheter shaft may be used, for example, to help properly position andalign the catheter shaft at a particular target site. In somevariations, a region of the shaft that is distal to a curve in the shaftmay define the same plane as a region of the shaft that is proximal tothe curve, or may even define the same plane as the rest of the shaft.In certain variations, however, a device may comprise a shaft having acurve, and a region of the shaft that is distal to the curve may definea plane that is different from a plane defined by a region of the shaftthat is proximal to the curve. The planes may be angled relative to eachother.

For example, FIG. 7A shows a primary anchor deployment catheter (700)comprising an elongated shaft (702) comprising a lumen (708). Elongatedshaft (702) has a curve (704) and includes a region (712) that is distalto the curve and a region (714) (FIG. 7B) that is proximal to the curve.As shown in FIG. 7A, primary anchor deployment catheter (700) alsocomprises an external stop (706), as well as an anchor (710) disposedwithin lumen (708) in region (712) of elongated shaft (702).

As shown both in FIGS. 7A and 7B, region (712) of elongated shaft (702)defines a plane (P1), and region (714) of elongated shaft (702) definesa different plane (P2). The planes have an angle (α₁) therebetween. Insome variations, angle (α₁) may be from about 10 degrees to about 90degrees (e.g., about 20 degrees to about 80 degrees, about 30 degrees toabout 75 degrees, about 40 degrees to about 70 degrees, about 40 degreesto about 60 degrees, about 50 degrees to about 70 degrees, or about 50degrees to about 60 degrees). For example, in certain variations, angle(α₁) may be about 60 degrees.

Angle (α₁) may be selected, for example, to help with the positioningand alignment of region (714) of elongated shaft (702) at a target site.For example, FIG. 7C is an illustrative depiction of primary anchordeployment catheter (700) being positioned to deploy an anchor intoheart tissue. As shown there, a guide tunnel (753) is positioned withina subvalvular space (751) of a left ventricle of a heart, below a mitralvalve (799). Guide tunnel (753) comprises an outer catheter (752) and aninner catheter (754) located within a lumen of the outer catheter.Primary anchor deployment catheter (700) is positioned within a lumen ofinner catheter (754), and region (712) is advanced through a windowregion (756) of guide tunnel (753) and embedded into heart tissue (750).Primary anchor deployment catheter (700) may then be used to deployanchor (710) into mitral valve tissue (750). Angle (α₁) between regions(712) and (714) of shaft (702) of primary anchor deployment catheter(700) may, for example, help an operator to relatively easily deployanchor (710) into the desired target site and at the desired location.

Of course, other types of catheters and indeed, other types of devices,may include regions defining planes that are angled with respect to eachother. For example, FIG. 8A shows a secondary anchor deployment catheter(800) comprising an elongated shaft (802) comprising a lumen (808).Elongated shaft (802) has a curve (804) and includes a region (812) thatis distal to the curve and a region (814) (FIG. 8B) that is proximal tothe curve. As shown in FIG. 8A, secondary anchor deployment catheter(800) also comprises an anchor (810) disposed within lumen (808) inregion (812) of elongated shaft (802).

As shown both in FIGS. 8A and 8B, region (812) of elongated shaft (802)defines a plane (P3), and region (814) of elongated shaft (802) definesa different plane (P4). The planes have an angle (α₂) therebetween. Insome variations, angle (α₂) may be from about 10 degrees to about 90degrees (e.g., about 20 degrees to about 80 degrees, about 30 degrees toabout 75 degrees, about 40 degrees to about 70 degrees, or about 50degrees to about 60 degrees) For example, in certain variations, angle(α₂) may be about 50 degrees.

Angle (α₂) may be selected, for example, to help with the positioningand alignment of region (814) of elongated shaft (802) at a target site.For example, FIG. 8C is an illustrative depiction of secondary anchordeployment catheter (800) being positioned to deploy an anchor intoheart tissue. As shown there, a guide tunnel (853) is positioned withina subvalvular space (851) of a left ventricle of a heart, below a mitralvalve (899), Guide tunnel (853) comprises an outer catheter (852) and aninner catheter (854) located within a lumen of the outer catheter.Secondary anchor deployment catheter (800) is positioned within a lumenof inner catheter (854), and region (812) is advanced through a windowregion (856) of guide tunnel (853) and embedded into heart tissue (850).Secondary anchor deployment catheter (800) may then be used to deployanchor (810) into mitral valve tissue (850). Angle (α₂) between theplanes defined by regions (812) and (814) of shaft (802) of secondaryanchor deployment catheter (800) may, for example, help an operator torelatively easily deploy anchor (810) into the desired target site andat the desired location.

While anchor deployment catheters having one shaft have been described,some variations of anchor deployment catheters may comprise more thanone shaft (e.g., two shafts, three shafts, etc.). In certain variations,the multiple shafts of an anchor deployment catheter may be used todeploy multiple anchors from the catheter simultaneously. Similarly,multiple anchors may be pre-loaded into a single catheter shaft anddeployed therefrom, serially or sequentially. In a like manner, ananchor deployment catheter may also comprise an additional shaft, or anadditional lumen within a single shaft, which may be configured toinflate a balloon. This may, for example, aid in the deployment of thetissue anchors as the inflation of the balloon presses the anchorsagainst the tissue to provide greater apposition. The balloon may bemade from any appropriate material, such as nylon, polyethylene,polyurethane, or a combination (e.g., a mixture) thereof.

While certain variations of anchor deployment devices and methods havebeen described, other variations may also be employed to deploy one ormore anchors at a target site. For example, as discussed above, in somevariations, multiple (i.e., at least two) anchors may be housed within asingle anchor deployment device, and may be deployed from the device ata target site.

As an example, FIG. 9A is an illustrative depiction of a distal portionof an anchor deployment catheter (900) that may be used to house anddeploy multiple anchors. During use, the anchors may be deployed fromthe side of the catheter. As shown in FIG. 9A, anchor deploymentcatheter (900) comprises an elongated member (902) comprising threeanchor-housing segments (904), (906) and (908) and three flexiblesegments (910), (912) and (914), where each of the flexible segmentscomprises a notch (916), (918) or (920). While three anchor-housingsegments and three flexible segments are shown, other variations ofdevices may have a different number of anchor-housing segments and/orflexible segments, as appropriate. Moreover, the number ofanchor-housing segments may be different from the number of flexiblesegments.

Catheter (900) also includes a lumen (921) therethrough. While notshown, in some variations, a spine, such as a wire (e.g., a Nitinol wirethat is 0.009 inch in cross-sectional diameter, or a 302/304 stainlesssteel wire that is 0.005 inch in cross-sectional diameter) may bedisposed within lumen (921). In some such variations, the spine may helpto control the catheter's orientation during use (e.g., by biasing thecatheter). This may, for example, allow the catheter to be curved and/orto track along a certain curvature during use. Anchor-housing segment(904) contains a collapsed anchor (922), anchor-housing segment (906)contains a collapsed anchor (924), and anchor-housing segment (908)contains a collapsed anchor (926). A tether (927) passes into and out ofanchor deployment catheter (900), and is looped through the eyelets ofeach of anchors (922), (924) and (926). In some cases, tether (927) maybe fixedly coupled to at least one of the anchors, such as distal-mostanchor (926).

Referring now to FIG. 9B, a top view of anchor-housing segment (904) isdepicted. As shown there, anchor-housing segment (904) comprises aprotective shield (928) that may, for example, prevent anchor (922) fromaccidentally puncturing through the wall (930) of elongated member (902)at that location. However, shield (928) includes an aperture (as shown,a slit (932)) that allows for deployment of anchor (922) therethrough.While shield (928) includes only one aperture, some variations ofshields may include multiple apertures. Moreover, certain variations ofdevices may not include any shields.

Referring additionally now to FIG. 9C, the anchors in anchor deploymentcatheter (900) may be deployed using a pulling member (934) comprisingan elongated portion (936) and a bulbous portion (938) at one end of theelongated portion. Elongated portion (936) is looped through the eyeletsof each of anchors (922), (924) and (926) (as shown, for example, withrespect to eyelet (940) of anchor (922) in FIG. 9C). During use, anoperator may pull on elongated portion (936), so that bulbous portion(938) contacts each anchor and forces it out through the correspondingaperture in the anchor deployment catheter (e.g., slit (932) in shield(928), for anchor (922)). In some variations, an aperture may beconfigured to direct anchor legs in an orientation that is relativelyperpendicular to the target tissue surface during deployment. Tether(927) may also be released as the anchors are being released, or afterthe anchors have been released. In certain variations, anchor-housingsegments (904), (906) and (908) may be configured for tether (927) to bereleased therethrough (e.g., the anchor-housing segments may be actuatedto open like doors), Alternatively or additionally, tether (927) may berouted in a configuration (not shown) such that deployment of theanchors also results in deployment of the tether. As an example, tether(927) may be routed into each anchor-housing segment, through the eyeletof the anchor housed within the segment, and back out of theanchor-housing segment in the same location at which the tether enteredthe segment.

The presence of flexible segments (910), (912) and (914) may provideanchor deployment catheter (900) with flexibility during use, such thatthe anchor deployment catheter may, for example, be relatively easilyadvanced along a tortuous pathway. In some variations, flexible segments(910), (912) and (914) may be formed of one or more relatively flexiblematerials (e.g., GRILAMID® L-25 nylon 12 plastic), while anchor-housingsegments (904), (906) and (908) are formed of relatively stiff materials(e.g., GRILAMID® TR 55 nylon 12 plastic). Additionally, the presence ofthe relatively stiff anchors within the anchor-housing segments mayenhance the stiffness of those segments.

“Anchors,” for the purposes of this application, are defined to mean anyfasteners. The anchors may be made of any suitable material, may be anysuitable size, and may be of any suitable shape. The size of an anchormay depend largely upon the end use of the anchor. For example, anchorsto be used in the repair of cardiac valves generally will be muchsmaller in dimension than those anchors used to repair large wounds orto reduce the circumference of a large hollow body organ. The anchorsmay be made of one material or more than one material, such as one ormore polymers (e.g., biodegradable polymers), metals, alloys, and/orcombinations or mixtures thereof. The anchors may comprise C-shaped orsemicircular hooks, curved hooks of other shapes, straight hooks, barbedhooks, single or multiple loop anchors, clips of any kind, T-tags,rivets, plication elements (e.g., local plication elements such asstaples), non-plication elements, or any other suitable fastener(s). Inone variation, anchors may comprise two tips that curve in oppositedirections upon deployment, forming two intersecting semi-circles,circles, ovals, helices or the like. In some variations, the tips may besharpened or beveled. Certain variations of anchors may comprise fibrousand/or porous materials in the shape of bars, rods or pledgets. In somecases, the fibrous or porous materials may expand in volume during use.

In certain variations, the anchors may be self-deforming. By“self-deforming,” it is meant that the anchors are biased to change froma first undeployed shape to a second deployed shape upon release of theanchors from a restraint. Such self-deforming anchors may change shapeas they are released from a housing or deployed from a lumen or openingto enter annular tissue, and secure themselves to the tissue.Self-deforming anchors may be made of any suitable material such asspring stainless steel, or super-elastic or shape-memory material suchas nickel-titanium alloy (e.g., Nitinol). The anchors may be configuredto self-expand and self-secure into tissue, but need not be configuredin such a fashion.

In certain variations, anchors may comprise one or more bioactiveagents, including biodegradable metals and polymers. In some variations,anchors may comprise electrode components. Such electrodes may, forexample, sense various parameters including but not limited toimpedance, temperature and electrical signals. In certain variations,such electrodes may be used to supply energy to tissue at ablation orsub-ablation amounts. Anchors are described, for example, in U.S. patentapplication Ser. No. 11/202,474 (published as US 2005/0273138 A1), whichis hereby incorporated by reference in its entirety.

While anchors have been described, other types of implants may be usedwith the devices, methods, and kits described here, as appropriate. Forexample, an implant may include one or more leads or electrodes (e.g.,pacing electrodes, diagnostic electrodes, active electrodes), In somevariations, an implant may include a fabric implant or an annuloplastyring, alone or in combination with one or more anchors. Additionalexamples of implants include implants that deliver therapy, such asdrug-delivery implants, and implants that provide telemetry ofinformation, such as information about a target site. For example,implants may be used to deliver growth factors and/or geneticregenerative factors. Other types of suitable implants may also be used.

Coupling members may be made from any suitable or desirablebiocompatible material, and may be made of a single material or acombination of materials (e.g., a coupling member may be in the form ofone long piece of material, or may comprise two or more pieces).Moreover, coupling members may be braided or not braided, woven or notwoven, and/or reinforced and/or impregnated with one or more additionalmaterials. As non-limiting examples, a coupling member may be made from(1) a suture material (e.g., absorbable suture materials such aspolyglycolic acid and polydioxanone, natural fibers such as silk, andartificial fibers such as polypropylene, polytetrafluoroethylene (PTFE),polyester, polyester impregnated with polytetrafluoroethylene, nylon, aKEVLAR® brand fiber, a VECTRAN® brand fiber, etc.), (2) a suture-likematerial, (3) a metal (absorbable or non-absorbable), (4) a metal alloy(e.g., stainless steel), (5) a shape-memory material, such as ashape-memory alloy (e.g., a nickel titanium alloy), (6) otherbiocompatible material, or (7) any combination thereof. In somevariations, a coupling member may be in the form of a DACRON® polyesterstrip. In certain variations, a coupling member may comprisepolyethylene, such as high-density polyethylene (HDPE) or ultra-highmolecular weight polyethylene (UHMWPE). Some variations of couplingmembers may have a braided textile construction (e.g., including aminimum of four strands on one side of a braid). In certain variations,free ends of the braid strands may be heat-fused together. Somevariations of coupling members may be in the form of a wire, tether,thread, or string.

In certain variations, a coupling member may include multiple layers,and/or may include one or more coatings. For example, a coupling membermay be in the form of a polymer-coated wire. In some variations, acoupling member may comprise a combination of one or more sutures andone or more wires. As an example, a coupling member may be formed of asuture that is braided with a wire. Certain variations of couplingmembers may be in the form of monofilament or multifilament textileyarns or fibers.

In some variations, a coupling member may be formed of one or moreelectrode materials. In certain variations, a coupling member may beformed of one or more materials that provide for the telemetry ofinformation (e.g., regarding the condition of a target site).

While procedures for tightening or compressing tissue using one couplingmember have been described, other procedures for modifying tissue mayinvolve the use of multiple coupling members, such as 2, 3, 4, 5, or 10coupling members. When multiple coupling members are used, at least someof the coupling members may be associated with (e.g., fixedly attachedto) different anchors, and/or at least some of the coupling members maybe associated with (e.g., fixedly attached to) the same anchor. Thedevices and methods described herein may apply to single coupling memberprocedures, or to multiple coupling member procedures.

Some variations of coupling members may include one or more therapeuticagents (e.g., drugs, such as time-release drugs). As an example, acoupling member may be partially or entirely coated with one or moretherapeutic agents. In certain variations, a coupling member may be usedto deliver one or more growth factors and/or genetic regenerativefactors. In some variations, a coupling member may be coated with amaterial (e.g., a polymer) that encapsulates or controls the releaserate of one or more therapeutic agents, or in which one or moretherapeutic agents are embedded. The therapeutic agents may be used, forexample, to treat a target site to which the coupling member is fixedlyattached or otherwise secured. In certain variations, a coupling membermay include one or more lumens through which one or more therapeuticagents may be delivered.

In some variations, a coupling member may be marked to help with properplacement. For example, in some procedures, it may be desirable fordeployed anchors to be evenly spaced apart (e.g., 1 millimeter to 5millimeters apart). In such procedures, the coupling member may bemarked periodically to indicate to the operator where the next anchorshould be deployed.

In addition to deploying anchors, some variations of the methodsdescribed here may comprise loading one or more anchors into an anchordeployment device, such as an anchor deployment catheter (e.g., prior todeploying the anchors). As an example, an anchor may be loaded within alumen of a shaft of an anchor deployment catheter. In some variations,the anchor may be loaded through a distal opening in the anchordeployment catheter, such as an opening located at the distal end of theanchor deployment catheter. In certain variations, the anchor maycomprise an eyelet, and the method may also comprise passing a couplingmember into the lumen of the anchor deployment catheter, and through theeyelet of the anchor. In some variations, an anchor may be pre-coupledto a coupling member prior to being loaded into an anchor deploymentdevice. Once the target site has been reached, the anchor may bedeployed. It should be noted that an anchor may be loaded into acatheter at any point prior to deployment of the anchor. Thus, forexample, in some variations, an anchor deployment catheter may beprovided with one or more pre-loaded anchors therein, ready fordeployment.

The manner in which an anchor is loaded into a device may depend, forexample, on the particular configuration of the anchor used. In somevariations, one or more anchors may be back-loaded into an anchordeployment catheter. That is, the anchors may be aligned and pulledand/or pushed into the distal tip of the catheter. In certain variationsin which the anchors comprise at least two legs, the anchor legs may bealigned parallel to the shaft so that the tips of the anchor legs areflush with the tip of the catheter. A loading tool (e.g., a lasso) maybe useful in this respect.

In some variations, a distal anchor deployment portion of an anchordeployment catheter may have one or more slots therethrough. In thisway, one or more anchors may be loaded through the slot or slots andcompressed into the lumen of the shaft. As described above, a slot orslots may also be useful in allowing a coupling member to passtherethrough and through the eyelet(s) of the anchor(s).

After an anchor has been loaded into an anchor deployment catheter, acoupling member may be passed into the shaft of the catheter and throughthe eyelet of the anchor, as described above. Typically, this may occurwith a secondary anchor deployment catheter, since a primary anchordeployment catheter generally includes an anchor that is fixedly coupledto a coupling member, and that is loaded into the primary anchordeployment catheter together with the coupling member. However, in somevariations, a coupling member may be coupled to an anchor after theanchor has already been loaded into a primary anchor deploymentcatheter. Methods for threading a coupling member into a catheter, suchas a primary anchor deployment catheter or a secondary anchor deploymentcatheter (e.g., after an anchor has been loaded into the catheter) areprovided below.

Any of a number of different variations of methods may be used to load acoupling member into a catheter. For example, FIGS. 10A and 10B depictexemplary variations of lassos that may be used to load a couplingmember (e.g., a tether) into a device, such as an anchor deploymentcatheter. As shown there, in some variations, a tether (1034) may beloaded into a device (1000) using a lasso (1004) comprising a loop(1006) at one end. First, one end of tether (1034) may be threadedthrough loop (1006) of lasso (1004). Lasso (1004) may then be pulledalong the longitudinal axis of device (1000) (FIG. 10A), to load tether(1034) into device (1000). In alternative implementations, shown in FIG.10B, a lasso (1054) having a loop (1055) may be pulled through a sidehole (1058) in a device (1050) to load a tether (1080) into the device.Lassos may be made from, for example, conventional materials such aswire, suture, cable, string, or a monofilament. A lasso may comprise aloop (as show in FIGS. 10A and 10B), a hook, a coil, a tube, an elongateelement with a hole, or any other structure or material that can “grab”a tether.

As described above, some variations of methods and devices describedhere may be used to retrieve an anchor that has been incorrectlydeployed (e.g., an anchor that has been deployed into a non-targetsite). For example, in certain variations, an anchor deployment cathetermay be capable of retrieving an anchor. As an example, an anchorretrieval method may comprise compressing an anchor or anchors down to acollapsed configuration, and drawing the anchor or anchors back into alumen of the catheter shaft. Any number of suitable devices or componentparts may be useful in the retrieval process. For example, as shown inFIG. 11A, in some variations an anchor retrieval process may comprisecoupling an anchor to a looped string or suture (1102) and loading theanchor into the anchor deployment catheter (1100). In this variation,the looped string (1102) is pulled distally (1104) out of catheter(1100), threaded onto one leg of the anchor (shown in FIG. 11A by dashedlines), and then slid around the anchor until it reaches, or ispositioned about, the eyelet. Once looped string (1102) has beenproperly threaded, the anchor may be loaded into the anchor deploymentcatheter by pulling proximally (1106) on looped string (1102). Here,proximal pulling on the looped string can cause the anchor's legs tocollapse against the anchor deployment catheter (1100), thereby allowingthe anchor to be pulled therein. The looped string may also function tohelp with proper alignment and/or loading of the anchor into the anchordeployment catheter.

In another variation, shown in FIG. 11B, an anchor deployment catheter(1108) comprises a pull-push wire (1110). In a manner similar to thatdescribed with respect to FIG. 11A above, an anchor (1112) is firstloaded or threaded onto push-pull wire (1110). This may be accomplished,for example, by pushing push-pull wire (1110) distally (1114) out ofcatheter (1108), and then loading anchor (1112) onto push-pull wire(1110) such that the distal hook of the push-pull wire (1110) isthreaded through the eyelet of anchor (1112). The anchor may then beloaded into catheter (1108) by proximal pulling (1116) of push-pull wire(1110). As with the variation described above, the push-pull wire mayalso function to help with proper alignment and/or loading of the anchorinto the anchor deployment catheter.

As described above, in certain variations, a procedure may be performedto deploy coupled anchors (e.g., tethered anchors) to a mitral valveregion. FIGS. 12A-12D illustrate provide additional detail on avariation of such an anchor deployment method.

As shown in FIG. 12A, in one variation, a distal portion (1202) of ananchor deployment catheter (1200) may be positioned in a desiredlocation under a valve leaflet (L) and adjacent a ventricular wall (VW).The valve annulus (VA) generally comprises an area of heart wall tissueat the junction of the ventricular wall (VW) and the atrial wall (AW)that is relatively fibrous and, thus, significantly stronger thanleaflet tissue and other heart wall tissue. It is noted, however, thatconsiderable structural variations of the annulus exist within patientpopulations and that attempted delivery of an implant to the valveannulus (VA) may instead result in the implant contacting or attachingto the tissue adjacent to the valve annulus. The term “annular tissue”as used herein shall include the valve annulus and the tissue adjacentto or surrounding the valve annulus.

Distal portion (1202) of anchor deployment catheter (1200) may beadvanced into position generally under valve annulus (VA) by anysuitable technique, such as one of the techniques described herein.Distal portion (1202) of anchor deployment catheter (1200) may be usedto deploy anchors to the valve annular tissue, to stabilize and/orexpose the annulus, or both. In one variation, using anchor deploymentcatheter (1200) having a flexible elongate body, flexible distal portion(1202) may be positioned in the left ventricle (LV) at the level of themitral valve leaflets using any of a variety of access routes describedherein. Distal portion (1202) may be advanced under the posterior valveleaflet into a space such as the subannular groove region (1204) or inthe subvalvular space (1206) (FIG. 12A). It has been found that whenanchor deployment catheter (1200) is passed, for example, under themitral valve via an intravascular approach, anchor deployment catheter(1200) may be inserted into the subannular groove region (1204) or thesubvalvular space (1206) and advanced either partially or completelyaround the circumference of the valve. Once in subannular groove region(1204) or the subvalvular space (1206), distal portion (1202) of anchordeployment catheter (1200) may be positioned proximate to theintersection of the valve leaflet(s) and ventricular wall (VW), which isnear valve annulus (VA). These are but examples of possible accessroutes of a catheter to a valve annulus, and any other appropriateaccess routes may be used.

In some variations, it may be advantageous to provide anchor deploymentcatheter (1200) with a curvable portion having a radius in anexpanded/curved state that is greater than a radius of the valveannulus, the subannular groove region or the ventricular chamber. Therelative size of this portion of anchor deployment catheter (1200), whenpositioned within the smaller sized ventricle, may exert a radiallyoutward force that can improve the surface contact between anchordeployment catheter (1200) and left ventricle (LV). For example, in onevariation, anchor deployment catheter (1200) in the expanded state mayhave a radius about 10% to about 50% larger than that of the valveannulus. Additionally, certain variations of anchor deployment cathetersmay further include one or more expandable members (e.g., balloons) thatmay expand to urge or press or wedge the anchor deployment catheter intoa target site (e.g., in the subvalvular space).

In addition to deploying anchors to the annular tissue, anchordeployment catheter (1200) (and specifically distal portion (1202)) maybe used to stabilize and/or expose the valve annulus or annular tissue.Such stabilization and exposure are described, for example, in U.S.patent application Ser. No. 10/656,797 (published as US 2005/0055087A1), which is hereby incorporated by reference in its entirety. Forexample, once distal portion (1202) is positioned generally under theannular tissue, force may be applied to distal portion (1202) tostabilize valve annulus (VA) or annular tissue, as shown in FIG. 12B.Such force may be directed in any suitable direction to expose, positionand/or stabilize the annulus or annular tissue. In another example, anupward and lateral force is shown in FIG. 12B by the solid-headed arrowdrawn from the center of distal portion (1202). In other examples, onlyupward, only lateral, or any other suitable force(s) may be applied.With application of force to distal portion (1202), the annular tissuemay rise or project outwardly, such that the annulus is exposed foreasier viewing and/or access. The applied force may also facilitatesurgical procedures and visualization by stabilizing valve annulus (VA)or valve annular tissue.

In some variations, additional force may be exerted by an anchordeployment device after the first anchor is engaged to body tissue. Thefirst anchor may provide additional leverage and stability formanipulating the anchor deployment device. For example, referring toFIGS. 12C and 12D, an anchor deployment device (1208) is schematicallyshown deploying an anchor (1210) to a valve annulus (VA) or annulartissue. Anchor (1210) is shown first housed within anchor deploymentdevice (1208) in FIG. 12C, and then deployed to annulus (VA) or annulartissue, as depicted in FIG. 12D. Of course, although the deployment andpositioning of anchor (1210) is described with respect to valve annulus(VA), one or more anchors (1210) may miss valve annulus (VA) and attachto other structures or tissues accessible from subannular groove region(1204) (or subvalvular space (1206)).

As shown, in some variations, anchors (1210) may have a relativelystraight configuration when housed in anchor deployment device (1208),with two penetrating tips and a loop in between the tips. Upondeployment from anchor deployment device (1208), the tips of an anchor(1210) may curve in opposite directions to form two semi-circles,circles, ovals, overlapping helices or the like. This is but one exampleof a type of self-securing anchor which may be deployed to annulartissue. Additional anchor variations are described, for example, in U.S.patent application Ser. No. 11/202,474 (published as US 2005/0273138A1), which was previously incorporated by reference in its entirety.Multiple coupled anchors (1210) may be deployed, and the anchors (1210)may be drawn together to tighten the valve annulus.

Although the subannular groove region or subvalvular space of heart maybe reached using a retrograde route through the aorta to the heart,other access routes may also be used. For example, access to the heartmay also be transthoracic, with a delivery device being introduced intothe heart via an incision or port in the heart wall. Even open heartsurgical procedures may benefit from the methods and devices describedherein. In some variations, hybrid access involving a combination ofaccess methods described herein may be used. In one specific example,dual access to a valve may be achieved with a combination of venous andarterial access sites. User manipulation of both ends of a guidewireplaced across a valve may improve positioning and control of thecatheter and the implants. In other examples of hybrid access, bothminimally invasive and surgical access may be used to implant one ormore cardiac devices.

Other variations of methods may also include treatment of the tricuspidvalve annulus, tissue adjacent the tricuspid valve leaflets, or anyother cardiac or vascular valve. Thus, although the description hereindiscloses specific examples of devices and methods for mitral valverepair, the devices and methods may be used in any suitable procedure,both cardiac and non-cardiac. For example, in certain variations, themitral valve reshaping devices and procedures may also be used with thetricuspid valve, and some variations may be adapted for use with thepulmonary and/or aortic valves. Likewise, the devices and methods trulybe used in the left ventricle, the right ventricle, or either atrium,with any appropriate adaptations for a particular location being withinthe ability of a person of ordinary skill in the art. The devices andmethods may also be used with the eat vessels of the cardiovascularsystem, for example, to treat aortic root dilatation.

Access to the other chambers of the heart may be performed throughpercutaneous or venous cut-down access, including but not limited totransjugular, subclavicular, and femoral vein access routes. When venousaccess is established, access to the right atrium, the right ventricle,the tricuspid valve and other right-sided cardiac structures can occur.Furthermore, access to left-sided heart structures, such as the leftatrium, left ventricle, mitral valve and the aortic valve, may besubsequently achieved by performing a transseptal puncture procedure.Referring to FIG. 13 with a heart (H) shown in cross-section,transseptal puncture is traditionally performed using a Mullinsintroducer sheath with a Brockenbrough curved needle through theinteratrial septum to access the left atrium (LA), but any of a varietyof other transseptal puncture devices or kits may also be used. Afterpuncturing through left atrium (LA), supravalvular access to the mitralvalve may be achieved by a guide catheter (1350) having a tubular body(1354), with the distal portion (1352) of the guide catheter enteringthe subvalvular space (1306). Antegrade access to the left ventricle(LV) can also occur by crossing the mitral valve. Similarly, access fromthe right ventricle (RV) to left ventricle (LV) may be obtained bytransseptal puncture of the ventricular septum. In still othervariations, a catheter device may access the coronary sinus and a valveprocedure may be performed directly from the sinus.

Surgical approaches that may be used include, but are not limited to,transcatheter procedures made through surgical incisions in the aorta ormyocardium. In one particular variation, depicted in FIG. 14, atransapical approach with a surgical delivery device (1414) is utilized,to provide a guide catheter (1402) with a more linear route to thesubvalvular space. The transapical approach also reduces potentialeffects of a myocardial incision on cardiac output, as the apical wall(1412) typically contributes less mechanical effect on left ventricularejection fraction compared to other sections of the myocardial wall.

While heart valve repair has been described, in certain variations, thedevices, methods, and/or kits described here may be used in a heartreshaping procedure, such as a ventricular remodeling procedure that isused to repair a heart experiencing valve dysfunction. Heart repairprocedures, including heart reshaping procedures, are described, forexample, in U.S. patent application Ser. No. 12/253,792 (published as US2009/0234318 A1), which is hereby incorporated by reference in itsentirety. Moreover, as discussed above, the devices, methods, and/orkits described herein may be used, as appropriate, in any of a number ofdifferent sites within the body and/or to assist with any of a number ofdifferent types of procedures. As an example, the devices, methods,and/or kits described herein may be used in NOTES procedures. As anotherexample, the devices, methods, and/or kits described herein may be usedin heart procedures other than those involving mitral valve repair. Forexample, they may be used to repair an aortic valve or a tricuspidvalve, or to secure a prosthetic heart valve, or they may be used inheart ports. As an additional example, the devices, methods, and kitsmay be employed in a procedure in which one or more tethers are used toreinforce an annuloplasty ring.

Kits are also described here. In some variations, the kits may includeat least one anchor deployment catheter. In certain variations, the kitsmay further include at least one guide catheter and/or at least oneguide tunnel. In some variations, a kit may include multiple (e.g., 2,3, 4, 5) different anchor deployment catheters. For example, a kit mayinclude at least one primary anchor deployment catheter and at least onesecondary anchor deployment catheter, or may include multiple secondaryanchor deployment catheters. Additional examples of anchor deploymentdevices (and related methods) are disclosed, for example, in U.S. patentapplication Ser. No. 11/201,949 (published as US 2007/0055206 A1) andSer. No. 11/583,627 (published as US 2008/0172035 A1), both of which arehereby incorporated by reference in their entirety. Anchor deploymentdevices and related methods are also disclosed in U.S. ProvisionalApplication Ser. Nos. 61/160,230, filed on Mar. 13, 2009, and61/178,910, filed on May 15, 2009, both of which were previouslyincorporated by reference in their entirety. In certain variations, akit may include one or more cinching devices and/or one or moretermination devices (e.g., locking devices, cutting devices, orcombination locking and cutting devices). Cinching devices aredescribed, for example, in U.S. Provisional Application Ser. No.61/104,686, filed on Oct. 10, 2008, and U.S. patent application Ser. No.12/576,955, filed on Oct. 9, 2009, both of which are hereby incorporatedby reference in their entirety. Termination devices are described, forexample, in U.S. patent application Ser. No. 11/232,190 (published as US2006/0190030 A1); Ser. No. 11/270,034 (published as US 2006/0122633 A1);and Ser. No. 12/577,044 (filed on Oct. 9, 2009), each of which is herebyincorporated by reference in its entirety. Termination devices are alsodescribed in U.S. Provisional Application Ser. No. 61/104,681, filed onOct. 10, 2008, which is hereby incorporated by reference in itsentirety. Of course, instructions for use may also be provided with thekits. Moreover, the components of the kit may be packaged together orseparately.

While the devices, methods, and kits have been described in some detailhere by way of illustration and example, such illustration and exampleis for purposes of clarity of understanding only. It will be readilyapparent to those of ordinary skill in the art in light of the teachingsherein that certain changes and modifications may be made theretowithout departing from the spirit and scope of the appended claims.

What is claimed is:
 1. An anchor delivery catheter comprising: a tubularelongated member having a proximal end, a distal end, a side portiontherebetween and a lumen therethrough; an elongated wire extending fromthe side portion, wherein a bend in the elongated wire signals to anoperator when to stop advancing the tubular elongate member; an anchorlocated within the lumen; a first anchor-retaining notch located withinthe lumen of the tubular elongated member; and a second anchor-retainingnotch, wherein retaining the anchor within the first and second notchesorients the anchor for deployment.
 2. The catheter of claim 1, whereinthe anchor-retaining notches are configured to temporarily retain theanchor.
 3. The catheter of claim 1, further comprising an internal stopelement and the first anchor-retaining notch is located on the internalstop element.
 4. The catheter of claim 3, wherein the internal stopelement is radiopaque.
 5. The catheter of claim 3, wherein the internalstop element comprises a tubular member having a sidewall, and the firstanchor-retaining notch is extends along a length of the sidewall.
 6. Thecatheter of claim 5, further comprising a pushing member that isconfigured to be advanced into a lumen of the tubular member.
 7. Thecatheter of claim 3, wherein the internal stop element is separate fromthe elongated wire.
 8. The catheter of claim 1, further comprising acoupling member coupled to the anchor.
 9. The catheter of claim 8,wherein the coupling member is a tether.
 10. The catheter of claim 1,wherein the tubular elongated member comprises a preformed shape havinga first region defining a first plane and a second region defining asecond plane at an angle with respect to the first plane.
 11. Thecatheter of claim 10, wherein the angle is from about 10 degrees toabout 90 degrees.
 12. The catheter of claim 1, wherein the bend in theelongated wire is a backward bend.
 13. The catheter of claim 1, whereinthe second anchor-retaining notch is located within the lumen of thetubular elongated member.